Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT02542072
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Results First Submitted: 2017-01-30
• Results First Submitted QC: 2017-01-30
• Results First Posted: 2017-03-21
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comfort	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 Outcome Measures

Name	Time	Method
Wearing Times	Baseline, 2 weeks, 4 weeks	Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
Biomicroscopy Scores	Baseline, 2 weeks, 4 weeks	Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Deterioration in Comfort	Baseline, 2 weeks, 4 weeks	Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent
Overall Lens Handling	Baseline, 2 weeks, 4 weeks	Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Film Deposits	2 weeks and 4 weeks	Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.
Comfortable Wearing Time Via SMS (Short Message Service)	Days 3, 12, 26	Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Vision Quality	Baseline, 2 weeks, 4 weeks	Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Visual Acuity (VA)	Baseline, 2 weeks, 4 weeks	Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
Lens Centration	Baseline, 2 weeks, 4 weeks	Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (\>0.5mm)
Corneal Coverage	Baseline Visit, 2 weeks follow-up, 4-weeks follow-up	Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.; Yes = coverage at all times or No = coverage incomplete
Post-Blink Movement	Baseline, 2 weeks, 4 weeks	Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Lens Tightness Push-up	Baseline, 2 weeks, 4 weeks	Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.; Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support
Dryness	Baseline, 2 weeks, 4 weeks	Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry
Lens Surface Wetting	Baseline, 2 weeks, 4 weeks	Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent
White Spot Deposits	2 weeks and 4 weeks	Number of white spot deposits for comfilcon A and samfilcon A lenses.
Primary Gaze Lag	Baseline, 2 weeks, and 4 weeks	Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Overall Fit Acceptance	Baseline, 2 weeks, 4 weeks	Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect

Trial Locations

Locations (5)

Golden Optometric Group; 🇺🇸 Whittier, California, United States

Complete Eye Care of Medina; 🇺🇸 Medina, Minnesota, United States

Brock & Houlford; 🇬🇧 Chew Magna, Bristol, United Kingdom

Tempany's Boutique Opticians; 🇬🇧 Broadstone, Dorset, United Kingdom

David Gould Opticians; 🇬🇧 Rawtenstall, Lancashire, United Kingdom