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
Overview
- Phase
- Phase 1
- Intervention
- 8% Dexamethasone Sodium Phosphate - Visulex
- Conditions
- Non-Infectious Anterior Uveitis
- Sponsor
- Aciont Inc
- Enrollment
- 44
- Locations
- 6
- Primary Endpoint
- Proportion of patients with anterior chamber cell ACC grade of zero
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
- •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.
Arms & Interventions
8% DSP-Visulex
8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
Intervention: 8% Dexamethasone Sodium Phosphate - Visulex
15% DSP-Visulex
15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
Intervention: 15% Dexamethasone Sodium Phosphate - Visulex
Pred Forte
Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.
Intervention: Prednisolone Acetate (1%) Eye Drops
Outcomes
Primary Outcomes
Proportion of patients with anterior chamber cell ACC grade of zero
Time Frame: Day 15
Secondary Outcomes
- 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 from baseline in anterior chamber cell (ACC) grade(Day 29)