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

A.T. Resolve SARL1 site in 1 country256 target enrollmentDecember 2014

ConditionsInflammation Pain Cataract

InterventionsRX-10045

DrugsRX-10045

Overview

Phase: Phase 2
Intervention: RX-10045
Conditions: Inflammation
Sponsor: A.T. Resolve SARL
Enrollment: 256
Locations: 1
Primary Endpoint: Proportion of Subjects With Clearing of Anterior Inflammation
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The 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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

September 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

A.T. Resolve SARL

Responsible Party

Sponsor

Eligibility Criteria

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