Skip to main content
OpenTrials
Completed

NCT Number: NCT02329743

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammation Cataract Eye Diseases Lens Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Auven Therapeutics

Murray Hill, New Jersey, 07974, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RX-10045

Drug

topical therapy

Primary outcomes

  1. Proportion of Subjects With Clearing of Anterior Inflammation

    Time frame: Day 8

    score of zero for the Standardization of Uveitis Nomenclature scale

Secondary outcomes

  1. Proportion of Subjects Reporting no Ocular Pain

    Time frame: Day 3

Sponsors and collaborators

Lead sponsor

A.T. Resolve SARL

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2015
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.