Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CooperVision, Inc.
- Enrollment
- 90
- Locations
- 5
- Primary Endpoint
- Comfort
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
- •Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
- •Spectacle cylinder 0.75D in both eyes.
- •Correctable to 6/9 (20/30) in both eyes
- •Be between 18 and 50 years of age (inclusive)
- •Able to read, comprehend and sign an informed consent
- •Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
- •Willing to comply with the wear and study visit schedule
Exclusion Criteria
- •Existing Biofinity or Ultra wearers
- •Any active corneal infection, injury or inflammation
- •Systemic or ocular allergies, which might interfere with Contact Lens wear
- •Systemic disease, which might interfere with Contact Lens wear
- •Ocular disease, which might interfere with Contact Lens wear
- •Strabismus or amblyopia
- •Subjects who have undergone corneal refractive surgery
- •Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
- •Pregnant or lactating
- •Use of systemic/topical medication contraindicating Contact Lens wear
- •Site employees or family members of site employees
Arms & Interventions
comfilcon A
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
Intervention: comfilcon A (Device)
samfilcon A
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
Intervention: samfilcon A (Device)
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
- Lens Tightness Push-up(Baseline, 2 weeks, 4 weeks)
- Dryness(Baseline, 2 weeks, 4 weeks)
- 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 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)