Title
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
A Multicenter, Double-Masked, Parallel-Group, Vehicle-Controlled Study to Assess the Efficacy and Safety of RX-10045 Nanomicellar Ophthalmic Solution for Treatment of Ocular Inflammation and Pain in Subjects Undergoing Cataract Surgery
Phase
Phase 2Lead Sponsor
A.T. Resolve SARLStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Inflammation Pain CataractIntervention/Treatment
rx-10045 ...Study Participants
256The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.
Inclusion Criteria: Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag. Exclusion Criteria: Any additional surgical procedures at the time of the cataract surgery Refractive surgery in the study eye within the past 2 years History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye Intraocular pressure of > 21 mm Hg in either eye Proliferative or severe nonproliferative diabetic retinopathy in either eye Neovascular/wet age-related macular degeneration in either eye
| Event Type | Organ System | Event Term |
|---|
score of zero for the Standardization of Uveitis Nomenclature scale
