Clinical Trial: RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

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

Official Title: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell L

Brief Summary: This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.

Detailed Summary:

Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects.

This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.


Sponsor: Reata Pharmaceuticals, Inc.

Current Primary Outcome: Count of corneal endothelial cells [ Time Frame: 12 weeks ]

Count of corneal endothelial cells 12 weeks post cataract surgery, compared to baseline


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Measure of inflammation [ Time Frame: 2 weeks ]
    Determine number of patients who have no inflammation 2 weeks post cataract surgery according to the Standardization of Uveitis Nomenclature (SUN) Working Group Inflammatory Scoring System
  • Measure of pain [ Time Frame: 1 day ]
    Determine number of patients who have no pain 1 day post cataract surgery according to the National Institutes of Health (NIH) Numeric Pain Rating Scale


Original Secondary Outcome: Same as current

Information By: Reata Pharmaceuticals, Inc.

Dates:
Date Received: April 28, 2014
Date Started: May 2014
Date Completion:
Last Updated: January 27, 2016
Last Verified: January 2016