Clinical Evaluation of Reusable Soft Contact Lenses

NCT06119191 | Completed Results FDA Device

• 1 other identifier: CV-23-86
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 5

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Lenses

EXPERIMENTAL

Participants wore Control Lenses for 30±2 days.

Device: Control Lenses (comfilcon A with current process)

Test Lenses

EXPERIMENTAL

Participants wore Test Lenses for 30±2 days.

Device: Test Lenses (comfilcon A with novel process)

Interventions

Control Lenses (comfilcon A with current process) DEVICE

Daily wear lenses for 30±2 days

Control Lenses

Test Lenses (comfilcon A with novel process) DEVICE

Daily wear lenses for 30±2 days

Test Lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead

Study Sites (5)

Clinical Research Center, UC Berkeley

Berkeley, California, 94720, United States

Location

Clinical Optics Research Lab at IU School of Optometry

Bloomington, Indiana, 47405, United States

Location

SUNY College of Optometry Clinical Vision Research Center

New York, New York, 10016, United States

Location

Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

ProCare Vision Center, Inc.

Granville, Ohio, 43023, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Cameron Postnikoff
• Organization: CooperVision, Inc.

postnikoff@coopervision.com

925-730-6734

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 14, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 8, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-02

Locations

US (5)