NCT02235259已完成2 期
A Phase II, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of XG-104 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAESM ) Model for the Treatment of Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Xigen SA
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4 week Three Times a Day (TID) treatment period
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 or desire to use eye drops
排除标准
- •Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Have used Restasis® within 30 days of Visit 1;
- •Have any planned ocular and/or lid surgeries over the study period;
- •Be a woman who is pregnant, nursing or planning a pregnancy;
- •Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential.
- •Have a known allergy and/or sensitivity to the study drug 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;
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
- •Be unable or unwilling to follow instructions, including participation in all study assessments and visits
研究组 & 干预措施
XG-104 low dose
Experimental
干预措施: XG-104 (Drug)
XG-104 intermediate dose
Experimental
干预措施: XG-104 (Drug)
XG-104 high dose
Experimental
干预措施: XG-104 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale
时间窗: Day 29
Worst Dry Eye Symptom
时间窗: From D22 to Day 28
次要结局
- Daily diary(up to Day 29)
- Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM(Day 29)
- Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM(Day 29)
- Tear Film Break-up Time (Pre- and Post-CAESM)(Day 29)
- Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)(Day 29)
- Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)(Day 29)
- Tear Osmolarity (Post-CAESM)(Day 29)
- Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology(Day 29)
- Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology(Day 29)
- Unanesthetized Schirmer's Test (Pre-CAESM)(Day 29)
- Drop Comfort and Symptom Assessment using Ora Calibra™ Scales(Day 15)
- Ocular Surface Disease Index (OSDI) (Pre-CAESM)(Day 29)
- Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)(Day 29)
- Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)(Day 29)
- Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)(Day 29)
研究者
研究点 (1)
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