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Clinical Evaluation of Reusable Soft Contact Lenses

NCT06119191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-04-08

Study results available
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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

Interventions

DEVICE

Control Lenses (comfilcon A with current process)

Daily wear lenses for 30±2 days

DEVICE

Test Lenses (comfilcon A with novel process)

Daily wear lenses for 30±2 days

Sponsors & Collaborators

  • CooperVision International Limited (CVIL)

    lead INDUSTRY

Principal Investigators

  • Meng C Lin, OD PhD · Clinical Research Center, UC Berkeley

  • Josianne Manasse, OD · SUNY College of Optometry Clinical Vision Research Center

  • Peter Kollbaum, OD PhD · Clinical Optics Research Lab at IU School of Optometry

  • Katherine Bickle, OD · ProCare Vision Center, Inc.

  • Jennifer S Fogt, OD MS · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2024-03-01
Completion
2024-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119191 on ClinicalTrials.gov