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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Aciont Inc
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Proportion of patients with anterior chamber cell ACC grade of zero
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-infectious anterior uveitis
排除标准
- •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.
研究组 & 干预措施
8% DSP-Visulex
8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
干预措施: 8% Dexamethasone Sodium Phosphate - Visulex (Drug)
15% DSP-Visulex
15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.
干预措施: 15% Dexamethasone Sodium Phosphate - Visulex (Drug)
Pred Forte
Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.
干预措施: Prednisolone Acetate (1%) Eye Drops (Drug)
结局指标
主要结局
Proportion of patients with anterior chamber cell ACC grade of zero
时间窗: Day 15
次要结局
- 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)