Expired Study
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Murray Hill, New Jersey 07974


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

ATR-45-1401


NCT ID:

NCT02329743


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

A.T. Resolve SARL


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

256


Enrollment Type:

Actual


Overall Contact Information

Official Name:Tomasz Sablinski, MD
Study Director
Auven Therapeutics

Study Dates

Start Date:December 2014
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 4, 2019
First Received Date:December 23, 2014
First Results Date:January 11, 2019

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:RX-10045
Description:topical therapy
Arm Name:RX-10045 0.05% nanomicellar solution

Study Arms

Study Arm Type:Experimental
Arm Name:RX-10045 0.05% nanomicellar solution
Description:topical eye drops
Study Arm Type:Experimental
Arm Name:RX-10045 0.1% nanomicellar solution
Description:topical eye drops
Study Arm Type:Placebo Comparator
Arm Name:Vehicle
Description:topical eye drops

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:A.T. Resolve SARL

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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