A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 230
- 试验地点
- 5
- 主要终点
- Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.
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
- Triple (Participant, 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
- •Signed Informed Consent Form and HIPAA document
- •Willing and able to comply with all study procedures
- •Be at least 18 years of age
- •Patient-reported history of dry eye in both eyes
- •Demonstrate a positive response when exposed to the Controlled Adverse Environment model
- •A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
排除标准
- •Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
- •Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period
- •Any blood donation or significant loss of blood within 56 days of Visit 1
- •Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
- •Use of any topical ophthalmic preparations (including tear substitutes) 72 hrs prior to screening assessments and through the entire study period
- •Any significant illness that could interfere with study parameters
- •History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.
- •Known history of alcohol and/or drug abuse
研究组 & 干预措施
5.0% Lifitegrast
Lifitegrast
干预措施: Lifitegrast (Drug)
Placebo
Placebo Ophthalmic Solution
干预措施: Placebo (Drug)
0.1% Lifitegrast
Lifitegrast
干预措施: Lifitegrast (Drug)
1.0% Lifitegrast
Lifitegrast
干预措施: Lifitegrast (Drug)
结局指标
主要结局
Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84
时间窗: Day 84
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
次要结局
- Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84(Baseline (Day 0) and Day 84)