Clinical Evaluation of Reusable Soft Contact Lenses

Completed · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT06119191

Run by

CooperVision International Limited (CVIL)

People needed

77

Starts

2023-11-14

Expected to finish

2024-03-01

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Research Center, UC Berkeley — Berkeley, California, United States
• Clinical Optics Research Lab at IU School of Optometry — Bloomington, Indiana, United States
• SUNY College of Optometry Clinical Vision Research Center — New York, New York, United States
• Ohio State University College of Optometry — Columbus, Ohio, United States
• ProCare Vision Center, Inc. — Granville, Ohio, United States

Full record on ClinicalTrials.gov

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