NCT01745887已完成1 期
A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome
Eleven Biotherapeutics1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- OSDI (Ocular Surface Disease Index)
研究概览
简要总结
This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.
详细描述
- To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES).
- To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses of EBI-005 ophthalmic solution.
- To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments.
- To investigate the comparative dose response of two different doses of EBI-005 ophthalmic solution.
- To investigate the comparative tolerability of two different doses of EBI-005 ophthalmic solution.
- To identify key biomarkers in the diagnosis and management of subjects with DES.
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
- •Provide written informed consent prior to any study related procedures
- •Are 18 years of age or older
- •Are women of child bearing potential (WOCBP) who are non-pregnant, non-lactating and sexually inactive (abstinent) for 14 days prior to Visit 1
- •Are willing and able to follow instructions and can be present for the required study visits for the duration of the study
- •Have a history of Dry Eye Syndrome in both eyes supported by a previous clinical diagnosis
- •Have ongoing Dry Eye Syndrome, in the same eye or both eyes, as defined by the following criteria:
- •A score of ≥23 on OSDI
- •A corneal fluorescein staining score of ≥6 (NEI scale)
- •Have normal lid anatomy
- •Are willing to withhold artificial tears for the duration of the study, with the exception of the study provided artificial tears: Refresh Plus®.
排除标准
- •Subjects may not:
- •Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept or Ilaris).
- •Have an OSDI score ≥90
- •Have a corneal fluorescein staining score of 15 (NEI scale). NOTE: If one of two eyes has a corneal fluorescein staining score of 15, the subject may be eligible.
- •Within 30 days prior to the screening visit (Visit 1) have taken: Topical cyclosporine (Restasis®) Ocular corticosteroids Autologous serum Topical ocular antibiotics Topical ocular antihistamines or mast cell stabilizers Topical or nasal vasoconstrictors
- •Within 30 days prior to the screening visit (Visit 1) have altered the dose of tetracycline compounds (tetracycline, doxycycline or minocycline).
研究组 & 干预措施
EBI-005-2 5mg/ml
Active Comparator
Administration: 3 times per day
干预措施: EBI-005-2 (Drug)
EBI-005-2 20 mg/ml
Active Comparator
Administration: 3 times per day
干预措施: EBI-005-2 (Drug)
结局指标
主要结局
OSDI (Ocular Surface Disease Index)
时间窗: 2 months
OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms
次要结局
- Symptom Assessment in Dry Eye (Modified SANDE)(2 months)
- Change from baseline in total corneal fluorescein staining(2 months)
研究者
研究点 (1)
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