Status:
COMPLETED
Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis
Lead Sponsor:
Aciont Inc
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Non-Infectious Anterior Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 anter...
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-Visu...
Eligibility Criteria
Inclusion
- Non-infectious anterior uveitis
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02309385
Start Date
October 1 2014
End Date
March 3 2017
Last Update
April 27 2017
Active Locations (6)
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1
Massachusetts Eye Research and Surgery Institution (MERSI)
Cambridge, Massachusetts, United States, 02142
2
Charlotte Eye, Ear, Nose, and Throat Associates
Charlotte, North Carolina, United States, 28210
3
Bergstrom Eye Research
Fargo, North Dakota, United States, 58103
4
B-Berger and Associates
Austin, Texas, United States, 78705