Clinical Trial: Safety and Efficacy of PG101 for Dry Eye Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary: 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.
Sponsor: Rhodes Pharmaceuticals, L.P.
Current Primary Outcome: At least one dry eye ocular symptom [ Time Frame: Up to 2 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: At least one dry eye ocular sign measure. [ Time Frame: Up to 2 weeks ]
Original Secondary Outcome: Same as current
Information By: Rhodes Pharmaceuticals, L.P.
Dates:
Date Received: December 20, 2013
Date Started: December 2013
Date Completion:
Last Updated: March 3, 2014
Last Verified: March 2014