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Multicenter Dispensing Study of Biofinity Lenses in Extended Range

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02060539
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : June 30, 2015
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Device: Biofinity XR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Dispensing Study of Biofinity Lenses in Extended Range
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biofinity XR
Participants dispensed Biofinity XR lenses over two weeks of lens wear
Device: Biofinity XR



Primary Outcome Measures :
  1. Dryness (During Day and Dryness at Night) [ Time Frame: Baseline ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.

  2. Dryness (During Day) [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  3. Dryness (During Day and Dryness at Night) [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.

  4. Comfort (Insertion, End of Day, Overall) [ Time Frame: Baseline ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.

  5. Comfort (Insertion) [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  6. Comfort (Insertion, End of Day, Overall) [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.

  7. Ghosting (Multiple Images) [ Time Frame: Baseline ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.

  8. Ghosting (Multiple Images) [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  9. Ghosting (Multiple Images) [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.

  10. Hazing (Blurred Edges) [ Time Frame: Baseline ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.

  11. Hazing (Blurred Edges) [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.

  12. Vision Quality (During Day and at Night) [ Time Frame: Baseline ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.

  13. Vision Quality (During Day) [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  14. Vision Quality (During Day and at Night) [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.

  15. Handling (Insertion, Removal, Overall) [ Time Frame: Baseline ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.

  16. Handling (Insertion, Removal, Overall) [ Time Frame: 2 weeks ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.

  17. Overall Satisfaction of Comfort, Vision, Handling [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  18. Overall Satisfaction of Comfort, Vision, Handling [ Time Frame: Baseline ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.

  19. Overall Satisfaction of Comfort, Vision, Handling [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.

  20. Comfort Preference [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  21. Comfort Preference [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

  22. Vision Preference [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  23. Vision Preference [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

  24. Handling Preference [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

  25. Overall Preference [ Time Frame: Dispense ]
    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  26. Overall Preference [ Time Frame: 2 Weeks ]
    Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.


Secondary Outcome Measures :
  1. Lens Centration - Habitual Lenses [ Time Frame: Baseline ]
    Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.

  2. Lens Centration [ Time Frame: Dispense ]
    Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.

  3. Lens Centration [ Time Frame: 2 Weeks ]
    Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.

  4. Lens Movement - Habitual Lenses [ Time Frame: Baseline ]
    Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.

  5. Lens Movement [ Time Frame: Dispense ]
    Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  6. Lens Movement [ Time Frame: 2 Weeks ]
    Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.

  7. Overall Fit Acceptance [ Time Frame: Baseline ]
    Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.

  8. Overall Fit Acceptance [ Time Frame: Dispense ]
    Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  9. Overall Fit Acceptance [ Time Frame: 2 Weeks ]
    Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.

  10. Visual Acuity [ Time Frame: Baseline ]
    Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.

  11. Visual Acuity [ Time Frame: Dispense ]
    Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.

  12. Visual Acuity [ Time Frame: 2 Weeks ]
    Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.

  13. Anterior Ocular Physiological Response [ Time Frame: Baseline ]
    Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.

  14. Anterior Ocular Physiological Response [ Time Frame: 2 Weeks ]
    Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.

  15. Average Wearing Time [ Time Frame: Baseline ]
    Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.

  16. Average Wearing Time [ Time Frame: 2 Weeks ]
    Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
  • Currently wears soft contact lenses
  • They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
  • Has clear corneas and no active ocular disease
  • Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

  • Has any systemic disease affecting ocular health
  • Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
  • Have any active ocular disease and/or infection that would contraindicate contact lens wear.
  • Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
  • Has worn gas permeable contact lenses within the last month.
  • Is aphakic
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of clinical research study
  • Female who is currently pregnant or is breast-feeding.

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): NCT02060539


Locations
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United States, California
UC Berkeley Clinica Research Center
Berkeley, California, United States, 94720-2020
United States, Indiana
CORL, Indiana University School of Optometry
Indianapolis, Indiana, United States, 46266-6057
United States, Texas
TERTC, University of Houston
Houston, Texas, United States, 77204-2020
Canada, Ontario
CCLR, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Lyndon Jones CCLR, University of Waterloo
Principal Investigator: Meng Lin CRC, University of California Berkeley
Principal Investigator: Jan Bergmanson TERTC, University of Houston
Principal Investigator: Pete Kollbaum CORL, Indiana University

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02060539     History of Changes
Other Study ID Numbers: CV-13-47
First Posted: February 12, 2014    Key Record Dates
Results First Posted: June 30, 2015
Last Update Posted: December 11, 2017
Last Verified: June 2015

Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases