Clinical Trial: RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

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

Official Title: A Multicenter, Randomized, Dose-Ranging, Double-Masked, Placebo-Controlled Phase 2 Study Evaluating the Safety and Efficacy of RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation an

Brief Summary: This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.

Detailed Summary: Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.
Sponsor: Reata Pharmaceuticals, Inc.

Current Primary Outcome: Anterior Chamber Cell Count [ Time Frame: 14 days ]

Count anterior chamber cells


Original Primary Outcome: Same as current

Current Secondary Outcome: Pain [ Time Frame: 14 days ]

Pain score on a visual analog scale


Original Secondary Outcome: Same as current

Information By: Reata Pharmaceuticals, Inc.

Dates:
Date Received: February 13, 2014
Date Started: February 2014
Date Completion:
Last Updated: October 30, 2014
Last Verified: October 2014