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Evaluation of Stenfilcon A Versus Etafilcon A

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ClinicalTrials.gov Identifier: NCT01809834
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
Evaluation of two contact lenses

Condition or disease Intervention/treatment Phase
Myopia Device: Etafilcon A Device: Stenfilcon A Phase 4

Detailed Description:
One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Evaluation of Stenfilcon A Versus Etafilcon A
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Etafilcon A
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Device: Stenfilcon A
Experimental: Stenfilcon A
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Device: Etafilcon A



Primary Outcome Measures :
  1. Participant's Subjective Rating of Comfort (Questionnaire) [ Time Frame: Insertion, After Lens settling, 12-hours, 1-week ]
    Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week

  2. Participant's Subjective Rating of Dryness (Questionnaire) [ Time Frame: 12-hours, 1-week ]
    Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week

  3. Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) [ Time Frame: Dispense ]
    Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing

  4. Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) [ Time Frame: 12-hours, 1-week ]
    Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week

  5. Participant's Subjective Rating of Visual Quality (Questionnaire) [ Time Frame: 12-hours, 1-week ]
    Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week

  6. Participant's Subjective Rating of Overall Preference (Questionnaire) [ Time Frame: 12-hours, 1-week ]
    Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week


Secondary Outcome Measures :
  1. Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) [ Time Frame: Insertion, 12 hours, 1 week ]

    Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced).

    Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week).


  2. Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) [ Time Frame: Insertion, 12 hours, 1 week ]

    Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good).

    Change over time measured at insertion, 12-hours, 1-week


  3. Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) [ Time Frame: Insertion ]

    Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination).

    (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.


  4. Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) [ Time Frame: Insertion, 12-hours, 1-week ]

    Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination).

    (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.


  5. Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) [ Time Frame: Baseline, 12-hours, 1-week ]
    Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week

  6. Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) [ Time Frame: Baseline, 12-hours, 1-week ]
    Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
  • Has astigmatism less than or equal to -1.00D;
  • Is an adapted soft contact lens wearer;
  • Demonstrates an acceptable fit with the study lenses;
  • Has no active anterior segment disease or known ocular disease.

Exclusion Criteria:

  • A person will be excluded from the study if he/she:
  • Has never worn contact lenses before;
  • Has any systemic disease affecting ocular health;
  • Is using any systemic or topical medications that will affect ocular health;
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
  • Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
  • Is aphakic;
  • Has undergone corneal refractive surgery;
  • Is participating in any other type of clinical or research study;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809834


Locations
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Canada, Ontario
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Lyndon Jones, PhD., FCO Univeristy of Waterloo, Canada

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01809834     History of Changes
Other Study ID Numbers: CV-12-57
First Posted: March 13, 2013    Key Record Dates
Results First Posted: June 27, 2014
Last Update Posted: June 27, 2014
Last Verified: June 2014