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Clinical Evaluation of Etafilcon A With Ketotifen

NCT03388138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2022-03-17

Study results available
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Summary

This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.

Conditions

  • Visual Acuity

Interventions

COMBINATION_PRODUCT

etafilcon A with ketotifen

Etafilcon A with ketotifen

DEVICE

1-Day ACUVUE

1-Day ACUVUE

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-06
Primary Completion
2018-02-09
Completion
2018-02-09
FDA Drug
Yes
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 NCT03388138 on ClinicalTrials.gov