Loading clinical trials...

Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis

A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis

NCT02309385•Aciont Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.

Detailed Description

This is a multicenter, randomized, parallel group, double-masked, active- controlled study. Subjects will be enrolled and randomized to either 8 % or 15% DSP-Visulex with placebo drops or Vehicle-Visulex (V-Visulex) with prednisolone acetate 1% eye drops. All subjects will receive concomitant treatment with cyclopentolate.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Non-infectious anterior uveitis

Exclusion Criteria

•lntraocular pressure \> 25mm Hg OU.
•Previous occurrence of an acute episode of anterior uveitis in affected eye(s) within 4 weeks prior to Visit 1.
•Historical or active intermediate or posterior uveitis in affected eye(s).
•Clear systemic causes of uveitis that may require or have required systemic treatment
•Uveitis suspected to have resulted from recent surgery or trauma.
•Use of ocular medication of any kind in affected eye(s) more than 2 days prior to Visit 1, excluding artificial tears, topical allergy medications, eyelid scrubs.
•Current use, or anticipated initiation during the study, of a corticosteroid or an immunosuppressant agent by any route (oral, inhaled, ocular, dermal). Current stable use is allowed.

Locations (6)

Massachusetts Eye Research and Surgery Institution (MERSI)

Cambridge, Massachusetts, United States

Charlotte Eye, Ear, Nose, and Throat Associates

Charlotte, North Carolina, United States

Bergstrom Eye Research

Fargo, North Dakota, United States

B-Berger and Associates

Austin, Texas, United States

Retina and Uveitis Consultants of Texas

San Antonio, Texas, United States

Moran Eye Center, University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

October 1, 2014

Primary Completion Date

March 3, 2017

Completion Date

March 3, 2017

Last Updated

April 27, 2017

Enrollment

ACTUAL participants

Conditions

Non-Infectious Anterior Uveitis

Interventions

8% Dexamethasone Sodium Phosphate - Visulex

DRUG

15% Dexamethasone Sodium Phosphate - Visulex

DRUG

Prednisolone Acetate (1%) Eye Drops

DRUG

Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis

NCT07285070

Non-infectious Anterior Uveitis

View study

COMPLETEDPHASE1/PHASE2

A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

NCT04222712

Non-infectious Anterior Uveitis

View study

COMPLETEDPHASE3

A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions