A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Ocular grittiness 6-point (0-5) scale
研究概览
简要总结
In subjects with Dry Eye Syndrome (DES):
The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.
详细描述
This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES).
Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.
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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Have a reported history of dry eye;
- •Have a history of use of eye drops for dry eye symptoms;
- •Symptoms of dry eye syndrome including:
- •Ocular discomfort
- •Conjunctival redness
- •Tear film break up time
- •Schirmer test score
- •Signs of dry eye syndrome including:
- •Conjunctival staining score
排除标准
- •Have any clinically significant slit lamp findings at entry visit ;
- •Be diagnosed with an ongoing ocular infection;
- •Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;
- •Have any planned ocular and/or lid surgeries over the study period;
- •Have an uncontrolled systemic disease;
- •Be a woman who is pregnant, nursing or planning a pregnancy;
- •Be a woman of childbearing potential who is not using an acceptable means of birth control;
- •Have a known allergy and/or sensitivity to the test article or its components;
- •Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
研究组 & 干预措施
Placebo to TOP1630 Ophthalmic Solution
干预措施: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU (Drug)
TOP1630 Ophthalmic Solution
干预措施: TOP1630 0.1% Ophthalmic Solution TID OU (Drug)
结局指标
主要结局
Ocular grittiness 6-point (0-5) scale
时间窗: Day 29
Ocular grittiness severity assessment
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
时间窗: Day 29
Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
次要结局
- Ocular discomfort 5-point (0-4) scale(Day 29)
- Ocular dryness 6-point (0-5) scale(Day 29)
- Conjunctival lissamine green staining score 5-point (0-4) scale each region(Day 29)
- Corneal lissamine green staining score 5-point (0-4) scale each region(Day 29)
- Worst ocular symptom 6-point (0-5) scale(Day 29)