Clinical Evaluation of Reusable Soft Contact Lenses
Study Details
Study Description
Brief Summary
The purpose of this study is to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This will be a prospective, multiple day, double (investigator and subject)-masked, randomized, bilateral re-fit parallel arm study comparing Test lenses against appropriate Control lenses. Participants will be randomized to wear either the Test or Control lenses, and the estimated duration of involvement is 4 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Control Lenses Participants will wear Control Lenses for 4 weeks |
Device: Control Lenses (comfilcon A with current process)
Daily wear lenses for 4 weeks
|
| Experimental: Test Lenses Participants will wear Test Lenses for 4 weeks |
Device: Test Lenses (comfilcon A with novel process)
Daily wear lenses for 4 weeks
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [4 weeks]
Monocular distance logMAR visual acuity will be measured at distance 4 meters under high illumination, high contrast conditions
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have had a self-reported oculo-visual examination in the last year.
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Are at least 18 years of age and has full legal capacity to give their informed consent.
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Have read and understood the informed consent letter.
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Are willing and able to follow instructions and maintain the appointment schedule.
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Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive)
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Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
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Have spectacle cylinder of ≤ 0.75 D in both eyes.
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Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours a day, 5 days per week)
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Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names:
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Bausch and Lomb BioTrue Multi-Purpose Solution
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Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution
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Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution
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Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution
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Alcon Opti-Free Replenish Multi-Purpose Solution
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Alcon Clear Care Plus Hydrogen Peroxide Solution
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Acuvue RevitaLens Multi-Purpose Solution
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Have clear corneas and no active ocular disease.
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Have not worn habitual lenses for at least 12 hours before the baseline/screening examination
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Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week
Exclusion Criteria:
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Have never worn contact lenses before.
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Are currently wearing daily disposable contact lenses.
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Have any systemic disease affecting ocular health.
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Are using any systemic or topical medications that will affect ocular health.
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Have any ocular pathology or abnormality that would affect the wearing of contact lenses.
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Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
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Are aphakic.
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Have undergone corneal refractive surgery.
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Are participating in any other type of eye related clinical or research study.
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Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: Pete Kollbaum, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CV-23-86