A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-Term Treatment of Signs and Symptoms of Dry Eye Disease (DED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 3
- 主要终点
- Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
研究概览
简要总结
To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.
详细描述
Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.
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
- •Dry Eye Disease diagnosis
- •VAS eye dryness severity score ≥ 40.
排除标准
- •Are unwilling to discontinue use of contact lenses
- •Are unwilling to withhold use of artificial tears.
研究组 & 干预措施
OTX-DED 0.2mg
Approximately 50 subjects
干预措施: OTX-DED (Drug)
OTX-DED 0.3mg
Approximately 50 subjects
干预措施: OTX-DED (Drug)
Hydrogel Vehicle (HV)
Approximately 50 subjects
干预措施: OTX-DED (Drug)
结局指标
主要结局
Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
时间窗: Change from baseline (Day 1) at Visit 4 (Day 15)
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia \[evaluated by the central reading center (CRC)\] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
次要结局
未报告次要终点