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Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear

NCT02555722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-09-25

Study results available
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Summary

This study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized, lens blocked (subjects remain in the same lens brand throughout the study) concurrent control study enrolling up to 90 subjects with a study duration of approximately three months. Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control).

Conditions

  • Myopia

Interventions

DEVICE

fanfilcon A (test)

silicone hydrogel lens

DEVICE

enfilcon A (control)

silicone hydrogel lens

Sponsors & Collaborators

  • CooperVision, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric M White, OD · Eric White, O.D., Inc.

  • Peter T Van Hoven, OD · Primary Eyecare Group, P.C.

  • Amanda L Barker, OD · Advanced Family Eye Care

  • Mark E Nakano, OD · Mark Nakano, O.D.

  • Thomas G Quinn, OD · Quinn, Foster & Associates

  • Mary Jo Stiegemeier, OD · Western Reserve Vision Care, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-21
Primary Completion
2016-01-27
Completion
2016-05-31
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 NCT02555722 on ClinicalTrials.gov