A Phase 3b Open-Label Study Designed to Evaluate Tear Production Stimulated by 0.003% AR-15512
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1
研究概览
简要总结
The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).
详细描述
Qualified subjects will attend a single visit.
This is a Phase 3b, 2-stage study. In Stage 1, approximately 40 subjects will be enrolled, after which the study will be paused and an interim analysis will be conducted. Results from the Stage 1 analysis will help inform the design of Stage 2. An additional 40 subjects are planned for Stage 2.
For both stages, the primary endpoint and analysis will remain the same. Stage 2 will be tested independently with no pooling of data between stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported.
- •Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms.
- •Corrected visual acuity score of 20/200 or better in both eyes.
- •Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history.
- •Other protocol specified inclusion criteria may apply.
排除标准
- •Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration).
- •History of ocular surgery within 1 year of the Study Visit.
- •Use of contact lenses in either eye within 7 days of the Study Visit.
- •Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit.
- •Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit.
- •Used artificial tears within 2 hours of the Study Visit.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
0.003% AR-15512
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
干预措施: 0.003% AR-15512 ophthalmic solution (Drug)
结局指标
主要结局
Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1
时间窗: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2
时间窗: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
次要结局
未报告次要终点