NCT03198000

A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.

Conditions

• Ophthalmic Solutions

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-28
• Primary completion: 2017-07-21
• Completion: 2017-07-21
• First posted: 2017-06-23
• Last updated: 2023-05-24
• Results posted: 2018-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study