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 ]

Dry eye ocular symptoms measured are: Ocular discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing.


Original Primary Outcome: Same as current

Current Secondary Outcome: At least one dry eye ocular sign measure. [ Time Frame: Up to 2 weeks ]

Dry eye ocular signs measured are: Corneal and conjunctival staining, tear break up time, OPI 2.0, Schirmer tear test, quality of life, and conjunctival redness


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