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Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

NCT03701516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2022-04-27

Study results available
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Summary

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Conditions

  • Myopia

Interventions

DEVICE

etafilcon A with novel molding process

TEST Lens

DEVICE

etafilcon A with current molding process

CONTROL Lens

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2019-04-01
Completion
2019-04-01
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 NCT03701516 on ClinicalTrials.gov