Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02128113
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 2
Start date May 31, 2014
Completion date April 30, 2015

See also
  Status Clinical Trial Phase
Completed NCT02573610 - Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery Phase 3
Completed NCT02910362 - Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines N/A
Recruiting NCT01193504 - Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification Phase 4
Completed NCT01199510 - Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery Phase 4
Completed NCT01455233 - 2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery Phase 4
Completed NCT04146961 - The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Completed NCT00585975 - Efficacy and Safety of Bromfenac Ophthalmic Solution Phase 2
Completed NCT00406913 - Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery N/A
Not yet recruiting NCT04131335 - Use of Prophylactic Lubricating Drops After Cataract Surgery N/A
Recruiting NCT05331690 - Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN) Phase 4
Withdrawn NCT04563559 - PREFERENTIAL Study Phase 2/Phase 3
Completed NCT04732351 - Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier
Completed NCT03873454 - The Effects of Music on Perioperative Outcomes in Cataract Surgery N/A
Completed NCT04769856 - Impact of Non-fasting on Anxiety in Cataract Surgery N/A
Withdrawn NCT00604305 - Comperative Trial Between an Accommodative Iol and Monofocal Iol N/A
Completed NCT05925894 - Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma. N/A
Not yet recruiting NCT06136780 - Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras N/A
Completed NCT04633954 - Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery N/A
Completed NCT03644875 - Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
Recruiting NCT04781231 - Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia N/A