North American Comfilcon A Clinical Study

August 25, 2025 updated by: CooperVision International Limited (CVIL)
The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.

Study Type

Observational

Enrollment (Estimated)

182

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 Backup

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720
        • Recruiting
        • University of Berkeley
        • Contact:
          • Meng C Lin, OD,PhD
    • Ohio
      • Granville, Ohio, United States, 43023
        • Recruiting
        • ProCare Vision Center
        • Contact:
          • Katherine Bickle, Dr.
    • Pennsylvania
      • College, Pennsylvania, United States, 16801
        • Recruiting
        • Nittany Eye Associates
        • Contact:
          • Abigail G Harsch, Dr.
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Recruiting
        • Drs. McIntyre, Garza, Avila and Jurica, Optometrists
        • Contact:
          • David Browning, Dr.

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female or male subjects aged 8 to 75 years who are established contact lens wearers. Screen and enrol approximately 182 participants wearing comfilcon A lenses with the aim of achieving at least 160 in the per protocol analysis cohort.

Description

Inclusion Criteria:

  1. Age 8 to 75 years (inclusive).
  2. Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
  3. At least occasional overnight wear in the last 12 months.

Exclusion Criteria:

1. Current participation in a contact lens or contact lens care product clinical trial.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
comfilcon A Sphere Lens Wearers
Habitual comfilcon A Sphere Lens Wearers
Device: comfilcon A Sphere lens
2 hours of wear
comfilcon A Toric Lens Wearers
Habitual comfilcon A Toric Lens Wearers
Device: comfilcon A Toric lens
2 hours of wear
comfilcon A Multifocal Lens Wearers
Habitual comfilcon A Multifocal Lens Wearers
Device: comfilcon A Multifocal lens
2 hours of wear
comfilcon A Multifocal Toric Lens Wearers
Habitual comfilcon A Multifocal Toric Lens Wearers
Device: comfilcon A Multifocal Toric lens
2 hours of wear
comfilcon A Energys Lens Wearers
Habitual comfilcon A Energys Lens Wearers
Device: comfilcon A Energys lens
2 hours of wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Performance (Visual Acuity)
Time Frame: At the end of 2 hours of wear

Visual Performance will be measured using logMAR

  • High contrast, high illumination distance VA
  • High contrast, high illumination near VA
At the end of 2 hours of wear
Incidence of contact lens-related adverse events
Time Frame: At the end of 2 hours of wear
Incidence of contact lens-related adverse events will be recorded from subjects
At the end of 2 hours of wear

Collaborators and Investigators

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

Sponsor

CooperVision International Limited (CVIL)

Collaborators

Centre for Ocular Research & Education, Canada

Investigators

  • Principal Investigator: Meng C Lin, OD, PhD, University of Berkeley
  • Principal Investigator: Katherine Bickle, Dr., ProCare Vision Center
  • Principal Investigator: Abigail G Harsch, Dr., Nittany Eye Associates
  • Principal Investigator: David Browning, Dr., Drs. McIntyre, Garza, Avila and Jurica, Optometrists

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)

February 5, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV-24-19

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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