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A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

NCT03198000 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-05-24

Study results available
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Summary

This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.

Conditions

  • Ophthalmic Solutions

Interventions

DRUG

F# 13418-148 Eye Drops

ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day

DRUG

F#13418-158 Eye Drops

ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day

DRUG

F# PF-004390 Eye Drops

Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Andover Eye Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2017-07-21
Completion
2017-07-21
FDA Drug
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 NCT03198000 on ClinicalTrials.gov