Status:
COMPLETED
Clinical Evaluation of Reusable Soft Contact Lenses
Lead Sponsor:
CooperVision International Limited (CVIL)
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.
Detailed Description
This was a prospective, multiple day, double-masked (investigator and subject), randomized, bilateral re-fit parallel arm study comparing a Test Lens against an appropriate Control Lens. Participants ...
Eligibility Criteria
Inclusion
- Have had a self-reported oculo-visual examination in the last year.
- Are at least 18 years of age and has full legal capacity to give their informed consent.
- Have read and understood the informed consent letter.
- Are willing and able to follow instructions and maintain the appointment schedule.
- Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive)
- Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Have spectacle cylinder of ≤ 0.75 D in both eyes.
- 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)
- Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names:
- Bausch and Lomb BioTrue Multi-Purpose Solution
- Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution
- Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution
- Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution
- Alcon Opti-Free Replenish Multi-Purpose Solution
- Alcon Clear Care Plus Hydrogen Peroxide Solution
- Acuvue RevitaLens Multi-Purpose Solution
- Have clear corneas and no active ocular disease.
- Have not worn habitual lenses for at least 12 hours before the baseline/screening examination
- Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week
Exclusion
- Have never worn contact lenses before.
- Are currently wearing daily disposable contact lenses.
- Have any systemic disease affecting ocular health.
- Are using any systemic or topical medications that will affect ocular health.
- Have any ocular pathology or abnormality that would affect the wearing of contact lenses.
- Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Are aphakic.
- Have undergone corneal refractive surgery.
- Are participating in any other type of eye related clinical or research study.
- Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT06119191
Start Date
November 14 2023
End Date
March 1 2024
Last Update
April 8 2025
Active Locations (5)
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1
Clinical Research Center, UC Berkeley
Berkeley, California, United States, 94720
2
Clinical Optics Research Lab at IU School of Optometry
Bloomington, Indiana, United States, 47405
3
SUNY College of Optometry Clinical Vision Research Center
New York, New York, United States, 10016
4
Ohio State University College of Optometry
Columbus, Ohio, United States, 43210