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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
307
Opthalmic suspension manufactured to mimic RTA 408 suspension
0.5% ophthalmic suspension of RTA 408
1% ophthalmic suspension of RTA 408
Harvard Eye Associates
Laguna Hills, California, United States
Hull Eye Center
Lancaster, California, United States
Argus Research
Change From Baseline in Central Corneal Endothelial Cell Counts
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
Time frame: 12 weeks
Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
Absence of of anterior chamber cells is defined as anterior chamber cells = 0
Time frame: 2 weeks
Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
Absence of of anterior chamber flare is defined as anterior chamber flare = 0
Time frame: 2 weeks
Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
Absence of of anterior chamber cells + flare is defined as anterior chamber cells + flare = 0
Time frame: 2 weeks
Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
Time frame: 1 day
Change From Baseline in Central Corneal Endothelial Cell Counts
Count of central corneal endothelial cells 6 weeks post cataract surgery, compared to baseline
Time frame: 6 weeks
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