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

Phase 2

Completed

• Conditions: Pain; Cataract; Inflammation
• Interventions: Drug: RX-10045

• Registration Number: NCT02329743
• Lead Sponsor: A.T. Resolve SARL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2015-01-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2019-01-11
• Results First Submitted QC: 2019-01-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Results First Posted: 2019-02-05
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	RX-10045	topical eye drops
RX-10045 0.1% nanomicellar solution	RX-10045	topical eye drops
RX-10045 0.05% nanomicellar solution	RX-10045	topical eye drops

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Clearing of Anterior Inflammation	Day 8	score of zero for the Standardization of Uveitis Nomenclature scale

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Reporting no Ocular Pain	Day 3

Trial Locations

Locations (1)

Auven Therapeutics; 🇺🇸 Murray Hill, New Jersey, United States