Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Coopervision, Inc.
- Enrollment
- 90
- Locations
- 5
- Primary Endpoint
- Comfort
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.
Detailed Description
This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Comfort
Time Frame: Baseline, 2 weeks, 4 weeks
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Secondary Outcomes
- Wearing Times(Baseline, 2 weeks, 4 weeks)
- Biomicroscopy Scores(Baseline, 2 weeks, 4 weeks)
- Deterioration in Comfort(Baseline, 2 weeks, 4 weeks)
- Overall Lens Handling(Baseline, 2 weeks, 4 weeks)
- Film Deposits(2 weeks and 4 weeks)
- Comfortable Wearing Time Via SMS (Short Message Service)(Days 3, 12, 26)
- Vision Quality(Baseline, 2 weeks, 4 weeks)
- Visual Acuity (VA)(Baseline, 2 weeks, 4 weeks)
- Lens Centration(Baseline, 2 weeks, 4 weeks)
- Corneal Coverage(Baseline Visit, 2 weeks follow-up, 4-weeks follow-up)
- Post-Blink Movement(Baseline, 2 weeks, 4 weeks)
- Lens Tightness Push-up(Baseline, 2 weeks, 4 weeks)
- Dryness(Baseline, 2 weeks, 4 weeks)
- Lens Surface Wetting(Baseline, 2 weeks, 4 weeks)
- White Spot Deposits(2 weeks and 4 weeks)
- Primary Gaze Lag(Baseline, 2 weeks, and 4 weeks)
- Overall Fit Acceptance(Baseline, 2 weeks, 4 weeks)