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

Phase 1

Completed

• Conditions: Non-Infectious Anterior Uveitis
• Interventions: Drug: 15% Dexamethasone Sodium Phosphate - Visulex; Drug: Prednisolone Acetate (1%) Eye Drops; Drug: 8% Dexamethasone Sodium Phosphate - Visulex

• Registration Number: NCT02309385
• Lead Sponsor: Aciont Inc

Brief 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15% DSP-Visulex	15% Dexamethasone Sodium Phosphate - Visulex	15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
Pred Forte	Prednisolone Acetate (1%) Eye Drops	Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.
8% DSP-Visulex	8% Dexamethasone Sodium Phosphate - Visulex	8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with anterior chamber cell ACC grade of zero	Day 15

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with anterior chamber cell ACC grade of zero	Day 29
Number of patients with treatment-emergent adverse events	29 days
Proportion of patients with no uveitis symptoms	29 days
Proportion of patients with improvement in visual acuity	29 days	Change in ETDRS letter score
Change from baseline in anterior chamber cell (ACC) grade	Day 29

Trial Locations

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

B-Berger and Associates; 🇺🇸 Austin, Texas, United States

Moran Eye Center, University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Bergstrom Eye Research; 🇺🇸 Fargo, North Dakota, United States

Retina and Uveitis Consultants of Texas; 🇺🇸 San Antonio, Texas, United States