Clinical trial NCT02309385: Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Infectious Anterior Uveitis
Keywords: uveitis
acute uveitis
anterior uveitis
dexamethasone sodium phosphate
non-infectious uveitis
DSP-Visulex
Aciont
Lead sponsor: Aciont Inc
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2014-12-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with anterior chamber cell ACC grade of zero
timeFrame: Day 15
Secondary outcomes:
measure: Number of patients with treatment-emergent adverse events
timeFrame: 29 days
measure: Proportion of patients with no uveitis symptoms
timeFrame: 29 days
measure: Proportion of patients with improvement in visual acuity
timeFrame: 29 days
measure: Change from baseline in anterior chamber cell (ACC) grade
timeFrame: Day 8
measure: Change from baseline in anterior chamber cell (ACC) grade
timeFrame: Day 15
measure: Change from baseline in anterior chamber cell (ACC) grade
timeFrame: Day 29
measure: Proportion of patients with anterior chamber cell ACC grade of zero
timeFrame: Day 8
measure: Proportion of patients with anterior chamber cell ACC grade of zero
timeFrame: Day 29
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts Eye Research and Surgery Institution (MERSI)
state: Massachusetts
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose, and Throat Associates
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research
state: North Dakota
city: Austin
country: United States
facility: B-Berger and Associates
state: Texas
city: San Antonio
country: United States
facility: Retina and Uveitis Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Moran Eye Center, University of Utah
state: Utah
Study officials:
affiliation: Aciont Inc
name: William I Higuchi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Weijtens O, Schoemaker RC, Romijn FP, Cohen AF, Lentjes EG, van Meurs JC. Intraocular penetration and systemic absorption after topical application of dexamethasone disodium phosphate. Ophthalmology. 2002 Oct;109(10):1887-91. doi: 10.1016/s0161-6420(02)01176-4.
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