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Novel Dexamethasone Sodium Phosphate Treatment (DSP-Visulex) for Noninfectious Anterior Uveitis: A Randomized Phase I/II Clinical Trial.

Abstract：

PURPOSE:Frequent steroid drops represent a challenge in patient compliance. This study evaluated the safety and efficacy of 5 minute topical dexamethasone sodium phosphate-Visulex (DSP-Visulex) treatment regimen (two applications on the first week then weekly after) compared to daily prednisolone acetate 1% (PA) for noninfectious anterior uveitis. MATERIALS AND METHODS:Forty-four patients were randomized to 8% DSP-Visulex with placebo eye drops (8% group, n = 14), 15% DSP-Visulex with placebo eye drops (15% group, n = 15), or Vehicle-Visulex with PA eye drops (PA group, n = 15). Patients received daily eye drops and Visulex treatments on days 1, 3, 8, and 15 with an optional treatment on day 22. Efficacy measures were change in anterior chamber cell (ACC) count from baseline and proportion of patients with zero ACC count at days 8, 15, and 29. Safety measures were adverse events (AEs), visual acuity, ocular symptoms, and intraocular pressure (IOP). RESULTS:ACC resolution over time was similar among the three groups. The percentage of patients with clear ACC was 18%, 22%, and 15% on day 8; 27%, 56%, and 54% on day 15; and 90%, 88%, and 77% on day 29 for the 8%, 15%, and PA groups, respectively. The numbers of reported AEs were 10, 36, and 12 for the 8%, 15%, and PA groups, respectively. Ten patients among all groups experienced treatment-related AEs, which included headache, eye pain, corneal abrasion, conjunctival/corneal staining, conjunctivitis, visual acuity reduction, and keratitis all of which were resolved during the timeframe of patients' participation in the study. IOP elevation was noted in the PA group throughout the study, whereas IOP elevation in the DSP-Visulex groups was observed at day 3 but not thereafter. CONCLUSIONS:The efficacy of the DSP-Visulex applications was comparable to the daily PA drops in the treatment of noninfectious anterior uveitis. Both 8% and 15% DSP-Visulex treatments were safe and well tolerated.

journal_name

Curr Eye Res

journal_title

Current eye research

authors

Papangkorn K,Truett KR,Vitale AT,Jhaveri C,Scales DK,Foster CS,Montieth A,Higuchi JW,Brar B,Higuchi WI

doi

10.1080/02713683.2018.1540707

subject

Has Abstract

pub_date

2019-02-01 00:00:00

pages

185-193

issue

eissn

0271-3683

issn

1460-2202

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Novel Dexamethasone Sodium Phosphate Treatment (DSP-Visulex) for Noninfectious Anterior Uveitis: A Randomized Phase I/II Clinical Trial.