Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery

A.T. Resolve SARL256 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

256

Conditions

Inflammation Pain Cataract

Interventions

RX-10045DRUG

topical therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Auven Therapeutics

Murray Hill, New Jersey, United States

Outcomes

Primary Outcomes

Proportion of Subjects With Clearing of Anterior Inflammation

score of zero for the Standardization of Uveitis Nomenclature scale

Time frame: Day 8

Secondary Outcomes

Proportion of Subjects Reporting no Ocular Pain

Time frame: Day 3

Data from ClinicalTrials.gov

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