Clinical Trial: A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate

Brief Summary: The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.

Detailed Summary: This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).
Sponsor: Rigel Pharmaceuticals

Current Primary Outcome: Change in corneal fluorescein staining [ Time Frame: Baseline and Visits 4, 8 and 12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in conjunctival lissamine green staining [ Time Frame: Baseline and Visits 4, 8 and 12 ]

Original Secondary Outcome: Same as current

Information By: Rigel Pharmaceuticals

Dates:
Date Received: November 21, 2012
Date Started: November 2012
Date Completion:
Last Updated: July 31, 2014
Last Verified: July 2014