A Phase 1 Study Evaluating Techniques for Measuring Tear Production
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Unanesthetized Schirmer test
研究概览
简要总结
This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.
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
- •Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
- •Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
- •Within the last year from Visit 1, have documented symptoms of DED
- •Corrected Visual Acuity (Snellen) 20/200 or better in both
排除标准
- •Use of artificial tears within 2 hours prior to Visit 1
- •Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
- •Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
- •Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
- •Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.
研究组 & 干预措施
Treatment with Schirmer test with anesthetic
Both eyes will be treated.
干预措施: 0.003% AR-15512 to be administered in both eyes (Drug)
Treatment with Schirmer test with no anesthetic
Both eyes will be treated.
干预措施: 0.003% AR-15512 to be administered in both eyes (Drug)
Treatment with Schirmer test with anesthetic
Both eyes will be treated.
干预措施: Vehicle to be administered in both eyes (Drug)
Treatment with Schirmer test with no anesthetic
Both eyes will be treated.
干预措施: Vehicle to be administered in both eyes (Drug)
结局指标
主要结局
Unanesthetized Schirmer test
时间窗: Day 1
Mean Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.
Anesthetized Schirmer test
时间窗: Day 1
Mean anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.
次要结局
未报告次要终点