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NCT02329743 Clinical Trial

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

Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02329743
Other study ID # ATR-45-1401
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2014
Est. completion date September 2015

Study information
Verified date February 2019
Source A.T. Resolve SARL
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• RX-10045
topical therapy

Locations
Country Name City State
United States Auven Therapeutics Murray Hill New Jersey

Sponsors (1)
Lead Sponsor Collaborator
A.T. Resolve SARL

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Subjects With Clearing of Anterior Inflammation score of zero for the Standardization of Uveitis Nomenclature scale Day 8
Secondary Proportion of Subjects Reporting no Ocular Pain Day 3
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