A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 21
- 主要终点
- Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score
研究概览
简要总结
This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.
详细描述
At the end of the Screening Visit, all qualified subjects will be assigned to administer one drop of AR-15512 Vehicle twice a day to both eyes for approximately 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 1:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 90 days. At the end of the Day 90 visit, subjects will exit the study.
Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs and symptoms of dry eye disease (DED) at the Screening and Baseline visits;
- •Corrected visual acuity of +0.70 logarithm Minimum angle of resolution (LogMAR) or better in both eyes at Screening and Baseline visits;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;
- •Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study;
- •Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study;
- •Medication use as specified in the protocol;
- •History or presence of significant systemic disease;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
0.003% AR-15512
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
干预措施: 0.003% AR-15512 ophthalmic solution (Drug)
AR-15512 Vehicle
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
干预措施: AR-15512 vehicle ophthalmic solution (Drug)
结局指标
主要结局
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score
时间窗: Baseline (Day 1) pre-drop; Day 14 post-drop
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.
次要结局
- Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score(Baseline (Day 1) pre-drop; Day 1 post-drop)
- Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28(Baseline (Day 1); Day 28)
- Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye)(Baseline (Day 1) pre-drop; Day 90 post-drop)
- Least Squares Mean Change From Baseline in Global SANDE Score on Day 90(Baseline (Day 1); Day 90)
- Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90(Baseline (Day 1); Day 90)
- Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90(Baseline (Day 1); Day 90)
- Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90(Baseline (Day 1); Day 90)
- Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)(Baseline (Day 1) pre-drop; Day 14 post-drop)
- Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90(Baseline (Day 1); Day 90)
- Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)(Baseline (Day 1) pre-drop; Day 1 post-drop)
- Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score(Baseline (Day 1) pre-drop; Day 90 post-drop)