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

• Status: Completed
• Trial end date: 2017-03-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aciont Inc
• Collaborator: National Eye Institute (NEI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tetrahydrozoline

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.