Synopsis:
This is a randomized, parallel group, double-masked, active-controlled clinical trial to evaluate the efficacy, safety and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) system for the treatment of non-infectious anterior uveitis. Approximately 45 eligible subjects will be enrolled in this study.
This study, sponsored by Aciont, Inc., will seek to determine the efficacy and safety of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis. This study aims to enroll 45 patients at multiple sites. Subjects will be randomized to receive 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.
The Visulex-passive system (Visulex-P) is a non-invasive drug delivery platform for treating sight threatening eye diseases. DSP-Visulex is intended for the treatment of patients with uveitis. Eligible male or female subjects will be at least 18 years of age and will be diagnosed with acute non-infectious anterior uveitis. Eligible subjects will also need to meet certain inflammation criteria. Certain conditions will exclude subjects from the study, for example, glaucoma, hyphema and certain medications.
The duration of the study is 29 days and includes 6 study visits. Study related procedures include standard ophthalmology examinations, visual acuity testing, fluorescein/lissamine green staining, and study drug administration. DSP-Visulex 8%, 15% and V-Visulex will be administered for 5 minutes during the treatment period. The treatment associated eye drops, either placebo or prednisolone acetate 1%, and cyclopentolate drops, will be self-administered according to dosing instructions that will be provided to all subjects.
Inclusion Criteria:
Exclusion Criteria:
The study includes:
More Information about the Sponsor: Aciont, Incorporated, https://aciont.com/.
Principal Investigator: C. Stephen Foster, M.D., F.A.C.S., F.A.C.R.
Research Coordinator: If you feel that you may be eligible for this study and are interested in participating, contact Stacey Lee, slee@mersi.com (781) 647-1431 x401.
If you are a study patient currently enrolled in this study, contact the Institutional Review Board, Quorum Review, at 1-888-776-9115 (Office hours are 8:00 AM to 5:00 PM Pacific Time, Monday through Friday). They are able to provide information on patient’s rights.
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