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

Completed · Phase 2

Conditions studied: Inflammation, Pain, Cataract

In brief

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.

Key facts

Study ID

NCT02329743

Run by

A.T. Resolve SARL

People needed

256

Starts

2014-12-01

Expected to finish

2015-09-01

Last updated by the study team

2019-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag.

You may not qualify if…

• 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

Where it is running

• Auven Therapeutics — Murray Hill, New Jersey, United States

Full record on ClinicalTrials.gov

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