A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 4
- 主要终点
- Symptom: Ocular discomfort score
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
详细描述
This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).
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
- 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 for at least 6 months prior to enrollment;
- •Have a history of use of eye drops
排除标准
- •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have used any eye drops within 2 hours of Visit 1;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception
研究组 & 干预措施
BRM421 Ophthalmic Solution
The active control with BRM421 solution
干预措施: BRM421 (Drug)
Placebo
The vehicle solution
干预措施: Placebo (Drug)
结局指标
主要结局
Symptom: Ocular discomfort score
时间窗: Up to 4 weeks
Sign: Corneal fluorescein staining score
时间窗: Up to 4 weeks
Sign: Corneal Fluorescein Staining Score
时间窗: change from baseline to week 4
The staining was graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The ocular surface was divided into three regions, including superior, central and inferior region. The following scale was used to grade staining of the each region. Half (0.5) grade increments may be used. The total score of corneal fluorescein staining was calculated as the sum of three regions, the score range is 0 (minimum) to 12 (maximum). None 0 = no staining Trace 1 = occasional Mild 2 = countable Moderate 3 = uncountable, but not confluent Severe 4 = confluent
Symptom: Ocular Discomfort Score
时间窗: change from baseline to week 4
Ocular discomfort scores was subjectively graded by the subjects according to the following Ora Calibra® Ocular Discomfort Scale, rating each eye separately, the score range is 0 (minimum) to 4 (maximum). 0 = no discomfort 1. = intermittent awareness 2. = constant awareness 3. = intermittent discomfort 4. = constant discomfort
次要结局
- Conjunctival Redness(Up to 4 weeks)
- Tear film break-up time(Up to 4 weeks)
- Ocular Surface Disease Index (OSDI)©(Up to 4 weeks)
- Tear Film Break-up Time(change from baseline to week 4)
- Conjunctival Redness(change from baseline to week 4)
- Ocular Surface Disease Index (OSDI)©(change from baseline to week 4)