A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Undilated Fundoscopy
研究概览
简要总结
In subjects with Dry Eye Syndrome:
The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.
The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.
详细描述
This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.
Eligible subjects will be randomized double masked to either TOP1630 or placebo.
Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.
Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy
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;
- •Additionally for Part 2
- •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
Active
TOP1630 Ophthalmic Solution
干预措施: TOP1630 Ophthalmic Solution (Drug)
Placebo
Placebo (Vehicle) Ophthalmic Solution
干预措施: Placebo to TOP1630 Ophthalmic Solution (Drug)
结局指标
主要结局
Undilated Fundoscopy
时间窗: Part 2: 35 days time frame
Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities
Visual Acuity
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
Visual Acuity will be measured using the EDTRS chart to assess changes from baseline
Vital Signs - Pulse
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline
Vital Signs - O2 Saturation
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline
Corneal Sensitivity
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6
Vital Signs - Systolic Blood Pressure
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline
Vital Signs - Diastolic Blood Pressure
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
Changes in vital signs is performed to assess changes from baseline
Drop Comfort Assessment
时间窗: Part 1: 12 days time frame
The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable
Slit-lamp Biomicroscopy
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities
Intraocular Pressure
时间窗: Part 1: 12 days time frame; Part 2: 35 days time frame
a non-contact tonometer will be used to perform IOP to assess changes from baseline.
次要结局
- Ocular Discomfort(Part 2: 35 days time frame)
- Dry Eye Symptoms(Part 2: 35 days time frame)
- Dry Eye Signs(Part 2: 35 days time frame)
- Tear Film Break up Time(Part 2: 35 days time frame)
- Schirmer's Test(Part 2: 35 days time frame)
- Daily Symptom Assessment(Assessed daily between visit 3b (day 27) to visit 4b (day 35))