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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02309385

Enrollment

Registered

2014-12-05

Start date

2014-10-31

Completion date

2017-03-03

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Infectious Anterior Uveitis

Keywords

uveitis, acute uveitis, anterior uveitis, dexamethasone sodium phosphate, non-infectious uveitis, DSP-Visulex, Aciont

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.

Interventions

DRUG8% Dexamethasone Sodium Phosphate - Visulex

DRUG15% Dexamethasone Sodium Phosphate - Visulex

DRUGPrednisolone Acetate (1%) Eye Drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with anterior chamber cell ACC grade of zero	Day 15

Secondary

Measure	Time frame	Description
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 8	—
Proportion of patients with anterior chamber cell ACC grade of zero	Day 8	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026