NCT05814757已完成2 期
A Randomized, Double-masked, Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
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
- 100
- 试验地点
- 1
- 主要终点
- Severity of Eye Dryness Score (visual analogue scale (VAS))
研究概览
简要总结
To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED
详细描述
Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.
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)
盲法说明
Double (Participant, Masked 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
- •VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
- •Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
- •Unanesthetized Schirmer of > 0 and ≤ 10 mm.
- •Must not have used Artificial Tears during the Screening period.
- •IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.
排除标准
- •Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
- •Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) < 5 mmHg or > 24 mmHg.
研究组 & 干预措施
OTX-DED 0.3mg
Experimental
干预措施: OTX-DED (Drug)
Controlled Insertion utilizing Collagen Punctal Plug
Experimental
干预措施: Controlled Insertion (Drug)
Collagen Punctal Plug (Full Insertion)
Placebo Comparator
干预措施: Collagen Punctal Plug (Drug)
结局指标
主要结局
Severity of Eye Dryness Score (visual analogue scale (VAS))
时间窗: Change from baseline (CFB) at Day 15
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
次要结局
未报告次要终点
研究者
研究点 (1)
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