Clinical Evaluation of Reusable Soft Contact Lenses

Clinical Evaluation of Comfilcon A Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Control Lenses (comfilcon A with current process); Device: Test Lenses (comfilcon A with novel process)

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • Clinical Research Center, UC Berkeley
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optics Research Lab at IU School of Optometry
  • New York
    • New York, New York, United States, 10016
      • SUNY College of Optometry Clinical Vision Research Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University College of Optometry
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Lenses; Participants wore Control Lenses for 30±2 days.	Device: Control Lenses (comfilcon A with current process); Daily wear lenses for 30±2 days
Experimental: Test Lenses; Participants wore Test Lenses for 30±2 days.	Device: Test Lenses (comfilcon A with novel process); Daily wear lenses for 30±2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.	4 weeks

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• Investigators: Principal Investigator: Meng C Lin, OD PhD, Clinical Research Center, UC Berkeley; Principal Investigator: Josianne Manasse, OD, SUNY College of Optometry Clinical Vision Research Center; Principal Investigator: Peter Kollbaum, OD PhD, Clinical Optics Research Lab at IU School of Optometry; Principal Investigator: Katherine Bickle, OD, ProCare Vision Center, Inc.; Principal Investigator: Jennifer S Fogt, OD MS, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-23-86

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes