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

February 4, 2019 updated by: A.T. Resolve SARL

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Murray Hill, New Jersey, United States, 07974
        • Auven Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RX-10045 0.05% nanomicellar solution
topical eye drops
Drug: RX-10045
topical therapy
EXPERIMENTAL: RX-10045 0.1% nanomicellar solution
topical eye drops
Drug: RX-10045
topical therapy
PLACEBO_COMPARATOR: Vehicle
topical eye drops
Drug: RX-10045
topical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Clearing of Anterior Inflammation
Time Frame: Day 8
score of zero for the Standardization of Uveitis Nomenclature scale
Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Subjects Reporting no Ocular Pain
Time Frame: Day 3
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.T. Resolve SARL

Investigators

  • Study Director: Tomasz Sablinski, MD, Auven Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (ESTIMATE)

January 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATR-45-1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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