NCT02078661

Safety and Efficacy of PG101 for Dry Eye Syndrome

A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Rhodes Pharmaceuticals, L.P. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

Detailed description

The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	PG101	A topical gel containing either 1% or 0.25% PG101 active.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-03-05
• Last updated: 2014-03-05

Locations

1 site across 1 country: United States