NCT02468700已完成2 期
A Prospective, Multicenter, Randomized, Parallel-Arm, Bilateral, Double-Masked, Vehicle Controlled Feasibility Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Total Conjunctival Lissamine Green Staining
研究概览
简要总结
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease
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
- Double (Participant, Investigator)
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
- •Had a known history of dry eye disease
- •Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye
排除标准
- •History of intraocular inflammation in either eye
- •Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study
- •Uncontrolled glaucoma or is on medications to treat glaucoma
- •History of IOP spikes in either eye
- •Active epiphora
研究组 & 干预措施
OTX-DP
Experimental
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
干预措施: Dexamethasone (Drug)
PV
Placebo Comparator
PV (placebo drug delivery vehicle)
干预措施: Placebo Vehicle (Other)
结局指标
主要结局
Total Conjunctival Lissamine Green Staining
时间窗: Day 30
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
Total Corneal Fluorescein Staining
时间窗: Day 30
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
次要结局
未报告次要终点
研究者
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