NCT01434277

Safety Evaluation of a New Preservative in a Lubricating Eye Drop

A Single-Center Study Evaluating the Safety of a New Preservative in an OTC Lubricant Eye Drop Used QID in Healthy Adults and in Subjects Diagnosed With Dry Eye

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety of a new preservative in a lubricant eye drop used four times a day in healthy adults and subjects diagnosed with dry eye.

Detailed description

Single-site, open-labeled study. Twenty two subjects will be enrolled into the healthy adult group and twenty two subjects into the dry eye group. Each subject will be in the study for approximately 2 weeks (treatment) and seen at three study Visits: Visit 1 (Day 0, Baseline), Visit 2 (Day 7 +/- 1) and Visit 3 (Day 14 +/- 1). Dosing regimen is 1-2 drops into each eye, four times daily, for two weeks. Assessments will be comprised of visual acuity, slit lamp biomicroscopy, fluorescein corneal staining, and product comfort.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
OTHER	Eye Drops with Experimental Preservative	Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-09-14
• Last updated: 2011-09-14

Locations

1 site across 1 country: United States