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Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01965288
First received: October 11, 2013
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.


Condition Intervention Phase
Astigmatism
Device: comfilcon A
Device: lotrafilcon B
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-Center Study Comparing the Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism Over 1 Month of Daily Wear.

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Daily and Comfortable Wearing Time [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)

  • Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

  • Vision Quality Insertion, During Day, End Day [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

  • Vision Stability Insertion, During Day, End Day [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

  • Overall Sensation of Moistness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

  • Overall Sensation of Smoothness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

  • Comfort Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Dryness Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Handling Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Lens Fit Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Vision Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Overall Satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Comfort Upon Contact Lens Insertion [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)

  • Vision Satisfaction Upon Contact Lens Insertion [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)

  • Vision Quality With Contact Lens Prescription [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

  • Vision Stability Upon Contact Lens Insertion [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

  • Visual Acuity logMAR [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).

  • Centration [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)

  • Corneal Coverage [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

  • Post Blink Movement [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

  • Lens Orientation Primary Gaze [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)

  • Lens Marking Visibility [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)

  • Lens Stability on Blink [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

  • Lens Stability 5-10 Min [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)

  • Lens Overall Stability [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)

  • Rotational Recovery 30/45 Deg [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

  • Overall Fit Acceptance [ Time Frame: Dispense ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

  • Daily and Comfortable Wearing Time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

  • Daily and Comfortable Wearing Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

  • Participants Use of Rewetting Drops [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)

  • Participants Use of Rewetting Drops [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)

  • Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

  • Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

  • Vision Quality Insertion, During Day, End Day, Night [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

  • Vision Quality Insertion, During Day, End Day, Night [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

  • Vision Stability on Insertion, During Day, End Day [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

  • Vision Stability on Insertion, During Day, End Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

  • Overall Sensation of Moistness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

  • Overall Sensation of Moistness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

  • Overall Sensation of Smoothness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

  • Overall Sensation of Smoothness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

  • Comfort Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Comfort Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Dryness Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Dryness Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Handling Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Handling Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Vision Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Vision Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Lens Fit Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Lens Fit Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Overall Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Overall Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

  • Wavefront Aberrations Root Mean Square (RMS) (3mm) [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

  • Wavefront Aberrations RMS (3mm) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

  • Wavefront Aberrations RMS (5mm) [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

  • Wavefront Aberrations RMS (5mm) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

  • Visual Acuity logMAR [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

    Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA).

    Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)


  • Visual Acuity logMAR [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

    Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA).

    Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)


  • Lens Orientation Primary Gaze [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

  • Lens Orientation Primary Gaze [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

  • Rotational Recovery 30/45 Deg [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

  • Rotational Recovery 30/45 Deg [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

  • Lens Surface Deposits [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

  • Lens Surface Deposits [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

  • Centration [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

  • Centration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

  • Corneal Coverage [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

  • Corneal Coverage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

  • Post Blink Movement [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

  • Post Blink Movement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

  • Lens Marking Visibility [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

  • Lens Marking Visibility [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

  • Lens Stability on Blink [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

  • Lens Stability on Blink [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

  • Lens Stability 5-10 Min [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

  • Lens Stability 5-10 Min [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

  • Overall Stability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.

  • Overall Stability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.

  • Overall Fit Acceptance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

  • Overall Fit Acceptance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)


Secondary Outcome Measures:
  • Limbal Hyperaemia [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Limbal Hyperaemia [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Limbal Hyperaemia [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Bulbar Hyperaemia [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Bulbar Hyperaemia [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Bulbar Hyperaemia [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Lower Palpebral Hyperaemia [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Lower Palpebral Hyperaemia [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Lower Palpebral Hyperaemia [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Stromal Haze [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Stromal Haze [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Stromal Haze [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Neovascularization [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Neovascularization [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Neovascularization [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Infiltrates [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Infiltrates [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Corneal Infiltrates [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

  • Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

  • Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

  • Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

  • Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

  • Participants Likelihood of Switching From Habitual Lenses to the Study Lenses [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses?" Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

  • Participants Likelihood of Continuing to Wear the Study Lenses. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participants likelihood of continuing to wear either of the pairs of study lenses when asked; "How likely are they to continue to wearing either the first study lenses or the second study lenses?" Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

  • Participant Recommendation of a Study Lens to Friends, Family or Colleagues [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of participants that answer the question, "What study lens they will most likely recommend to friends, family or colleagues?" Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)

  • Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of participants that answer the question, "How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues?" Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

  • Participant Preference for Their Habitual Lenses or Either of the Study Lenses [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)

  • Participant Preference for Either of the Study Lenses [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; first study lenses, second study lenses, neither)


Enrollment: 60
Study Start Date: September 2013
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: comfilcon A
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.
Device: comfilcon A
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Biofinity Toric
Device: lotrafilcon B
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Air Optix
Active Comparator: lotrafilcon B
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.
Device: comfilcon A
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Biofinity Toric
Device: lotrafilcon B
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Air Optix

Detailed Description:

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft toric contact lens wearer
  • Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
  • Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Has a contact lens prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
  • Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (past or present)
    • Seborrheic eczema, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965288

Locations
Spain
Optometry Research Group (GIO) - Optics Department, University of Valencia
Valencia, Spain
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Robert Montés-Mico, OD MPhil PhD Optometry Research Group (GIO) - Optics Department, University of Valencia
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01965288     History of Changes
Other Study ID Numbers: EX-MKTG-42
Study First Received: October 11, 2013
Results First Received: October 10, 2014
Last Updated: November 6, 2014
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Astigmatism
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 25, 2014