NCT00893139已完成2 期
A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for 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
- 入组人数
- 765
- 主要终点
- Mean change from baseline in sodium fluorescein corneal staining score
研究概览
简要总结
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment 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
- 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
- •Composite corneal staining score of greater than 5 in one or both eyes.
- •Schirmer II score of greater than 4 mm.
- •OSDI score of greater than
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-38583 0.05%
Experimental
AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days
干预措施: AL-38583 ophthalmic solution 0.05% (Drug)
AL-38583 0.10%
Experimental
AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days
干预措施: AL-38583 ophthalmic solution 0.10% (Drug)
AL-38583 vehicle
Placebo Comparator
Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days
干预措施: AL-38583 vehicle (Drug)
结局指标
主要结局
Mean change from baseline in sodium fluorescein corneal staining score
时间窗: Baseline, up to Day 35
次要结局
- Mean change from baseline in phenol red thread length(Baseline, up to Day 35)
研究者
相似试验
撤回
2 期
To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen ChallengeAllergic ConjunctivitisNCT00881673Alcon Research
已完成
2 期
AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated InflammationAllergic ConjunctivitisNCT01001091Alcon Research312
已完成
3 期
A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye DiseaseDry Eye DiseaseNCT06544694Alcon Research79
终止
3 期
Geographic Atrophy Treatment EvaluationGeographic AtrophyAge-Related Macular DegenerationNCT00890097Alcon Research772
已完成
3 期
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic ConjunctivitisAllergic ConjunctivitisNCT01743027Alcon Research902