Clinical Evaluation of Reusable Soft Contact Lenses

March 31, 2025 updated by: CooperVision International Limited (CVIL)

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CooperVision International Limited (CVIL)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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