A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
研究概览
简要总结
The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Be at least 18 years of age of either gender and any race;
- •Have a reported history of dry eye for at least 6 months prior to Visit 1;
- •Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
排除标准
- •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Have used cyclosporine 0.05% or lifitegrast 5.0% ophthalmic solution within 45 days of Visit 1;
- •Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;
- •Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
研究组 & 干预措施
ADX-102 Ophthalmic Solution (0.5%)
干预措施: ADX-102 Ophthalmic Solution (0.5%) (Drug)
ADX-102 Ophthalmic Solution (0.1%)
干预措施: ADX-102 Ophthalmic Solution (0.1%) (Drug)
ADX-102 Ophthalmic Lipid Solution (0.5%)
干预措施: ADX-102 Ophthalmic Lipid Solution (0.5%) (Drug)
结局指标
主要结局
Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
时间窗: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.
Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
次要结局
未报告次要终点