A Phase 2 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Safety and Efficacy of ST-100 Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.
详细描述
This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1):
- Low dose ST-100 Ophthalmic Solution: 1 drop twice daily (BID) in each eye
- High dose ST-100 Ophthalmic Solution: 1 drop BID in each eye
- Placebo Ophthalmic Solution (Vehicle): 1 drop BID in each eye
Approximately 150 subjects will be randomly assigned to one of the three groups (1:1:1) to receive either ST-100 Ophthalmic Solution or placebo solution as topical ophthalmic drops administered bilaterally BID for 4 weeks. Subjects, Sponsor, Contract Research Organization (CRO), and site personnel will be masked to treatment assignment.
The clinical hypotheses for this study is that low dose and high dose ST-100 Ophthalmic Solution twice daily (BID) is superior to its vehicle (BID) for the primary endpoints of signs and symptoms 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
- 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 subject reported history of dry eye;
- •Have a history of use of eye drops for dry eye symptoms;
- •Have symptoms of dry eye as determined by Ocular Discomfort & 4-symptom questionnaire;
- •Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm;
- •Have conjunctival redness;
- •Have corneal fluorescein staining;
- •Have lissamine green conjunctival staining;
- •Have signs and symptoms responses to Controlled Adverse Environment (CAE®);
排除标准
- •Have any clinically significant slit lamp findings;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation ;
- •Have worn contact lenses;
- •Have used any eye drops;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery
- •Have used Restasis, Xiidra, or Cequa ophthalmic solutions
- •Have any planned ocular and/or lid surgeries or any ocular surgery;
- •Have used, are using or anticipate using permanent or temporary punctal plugs during the study;
- •Be currently taking any topical ophthalmic prescription;
- •Be currently taking or have taken Omega-3 supplements;
- •Be unable to read an eye chart;
- •Be a woman who is pregnant, nursing, or planning a pregnancy;
- •Be unwilling to submit a urine pregnancy test (or early termination visit) if of childbearing potential;
- •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 that 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;
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device;
- •Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen;
- •Have a known history of meibomian gland procedures (e.g., LipiFlow, LPI, probing, etc.);
- •Be unable or unwilling to follow instructions, including participation in all study assessments and visits.
研究组 & 干预措施
Low Dose ST-100 Ophthalmic Solution
Low Dose ST100-001 Ophthalmic solution, 20mcg/ml
干预措施: ST-100 Ophthalmic Solution (Drug)
High Dose ST-100 Ophthalmic Solution
High Dose ST100-001 Ophthalmic Solution, 50mcg/ml
干预措施: ST-100 Ophthalmic Solution (Drug)
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution (vehicle)
干预措施: Placebo Ophthalmic Solution (Drug)
结局指标
主要结局
Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE
时间窗: Visit 2 (Day 1) to Visit 7 (Day 29)
Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort.
Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE)
时间窗: Visit 2 (Day 1) to Visit 7 (Day 29)
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated.
次要结局
- Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)(Visit 6 (Day 15) Pre-CAE)
- Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)(Visit 4 (Day 4), Non-CAE)
- Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire(Visit 6 (Day 15) Pre-CAE)
- Unanesthetized Schirmer's Responder Rate(Visit 7 (Day 29), Pre-CAE)
- Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)(Visit 3 (Day 2))