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

NCT ID: NCT02329743

Last Updated: 2019-02-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation Pain Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RX-10045 0.05% nanomicellar solution

topical eye drops

Group Type EXPERIMENTAL

RX-10045

Intervention Type DRUG

topical therapy

RX-10045 0.1% nanomicellar solution

topical eye drops

Group Type EXPERIMENTAL

RX-10045

Intervention Type DRUG

topical therapy

Vehicle

topical eye drops

Group Type PLACEBO_COMPARATOR

RX-10045

Intervention Type DRUG

topical therapy

Interventions

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RX-10045

topical therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A.T. Resolve SARL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomasz Sablinski, MD

Role: STUDY_DIRECTOR

Auven Therapeutics

Locations

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Auven Therapeutics

Murray Hill, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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ATR-45-1401

Identifier Type: -

Identifier Source: org_study_id

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