Clinical Evaluation of Reusable Soft Contact Lenses

NCT ID: NCT06119191

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2024-03-01

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 were randomized to wear the Test or Control lens for 30±2 days.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Lenses

Participants wore Control Lenses for 30±2 days.

Group Type: EXPERIMENTAL

Control Lenses (comfilcon A with current process)

Intervention Type: DEVICE

Daily wear lenses for 30±2 days

Test Lenses

Participants wore Test Lenses for 30±2 days.

Group Type: EXPERIMENTAL

Test Lenses (comfilcon A with novel process)

Intervention Type: DEVICE

Daily wear lenses for 30±2 days

Interventions

Control Lenses (comfilcon A with current process)

Daily wear lenses for 30±2 days

Intervention Type: DEVICE

Test Lenses (comfilcon A with novel process)

Daily wear lenses for 30±2 days

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision International Limited (CVIL)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng C Lin, OD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center, UC Berkeley

Josianne Manasse, OD

Role: PRINCIPAL_INVESTIGATOR

SUNY College of Optometry Clinical Vision Research Center

Peter Kollbaum, OD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Optics Research Lab at IU School of Optometry

Katherine Bickle, OD

Role: PRINCIPAL_INVESTIGATOR

ProCare Vision Center, Inc.

Jennifer S Fogt, OD MS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-23-86

Identifier Type: -

Identifier Source: org_study_id