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

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.

Timeline

Start

2014-05-31

Primary completion

2015-02-28

Completion

2015-04-30

Outcome

Missed primary endpoint

registry analysis (superiority test); Vehicle Ophthalmic Solution vs Omaveloxolone Opthalmic Suspension 0.5%; p = 0.1276; LS Mean difference (Net) 64.31; ANCOVA NCT02128113 ↗

registry analysis (superiority test); Vehicle Ophthalmic Solution vs Omaveloxolone Opthalmic Suspension 1%; p = 0.7996; LS Mean difference (Net) -11.08; ANCOVA NCT02128113 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omaveloxolone	Small molecule	0.5 %	Other
Subject	Omaveloxolone	Small molecule	1 %	Other

Indications