RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
Condition: Corneal Endothelial Cell Loss; Ocular Pain; Ocular Inflammation; Cataract Surgery
MeSH terms: Cataract; Corneal Endothelial Cell Loss; Inflammation
Intervention: Vehicle Ophthalmic Solution; Omaveloxolone Ophthalmic Suspension 0.5%; Omaveloxolone Ophthalmic Suspension 1%
Intervention description: Opthalmic suspension manufactured to mimic RTA 408 suspension; 0.5% ophthalmic suspension of RTA 408; 1% ophthalmic suspension of RTA 408
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: RTA 408; Cataract surgery; Corneal Endothelial Cells; omaveloxolone

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be male or female and ≥18 years of age and ≤80 years of age

          2. Plan to undergo cataract extraction by phacoemulsification with the implantation of a
             posterior chamber intraocular lens

          3. Have the potential, in the opinion of the investigator, to improve best-corrected
             visual acuity in the study eye after surgery

          4. Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III

          5. Have corneal endothelium in the study eye that can be accurately assessed using
             specular microscopy

          6. Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening
             Visit

          7. Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of
             resolution (logMAR) in the study eye and fellow eye as measured using an Early
             Treatment for Diabetic Retinopathy Study (ETDRS) chart

        Exclusion Criteria:

          1. Have a score >0 on the ocular pain assessment at the Screening Visit or the
             Randomization Visit in the study eye

          2. Have an active immunosuppressive disease or an autoimmune disease that, in the opinion
             of the investigator, could affect the quality of the ocular surface

          3. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and
             will likely affect wound healing

          4. Have an intraocular pressure (IOP) ≤5 mmHg in either eye

          5. Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or
             be planning to have laser or incisional surgery during the study period in the study
             eye

          6. Have the presence of guttae Stage 2 or greater or other abnormality in the study eye
             that does not allow for accurate corneal endothelial cell assessments