临床试验/NCT01495338

NCT01495338已完成1 期

A Comparison of the Safety and Comfort of AC-170

Aciex Therapeutics, Inc.1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2011年12月最近更新: 2017年9月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Aciex Therapeutics, Inc.
入组人数: 60
试验地点: 1
主要终点: Drop Comfort Score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.

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: Single (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

•Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period.

排除标准

•Known contraindications or sensitivities to the study medication or its components.
•Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
•Use of disallowed medications during the period indicated prior to the study enrollment or during the study.

研究组 & 干预措施

AC-170 0.24% (Formulation 1)

Experimental

干预措施: AC-170 0.24% (Formulation 1) (Drug)

AC-170 0.24% (Formulation 2)

Experimental

干预措施: AC-170 0.24% (Formulation 2) (Drug)

Olopatadine hydrochloride 0.2%/Tears Naturale II

Placebo Comparator

干预措施: Olopatadine hydrochloride 0.2%/Tears Naturale II (Drug)

AC-170 0.17%

Experimental

干预措施: AC-170 0.17% (Drug)

结局指标

主要结局

Drop Comfort Score

时间窗: during 3 minute period

drop comfort on 0-10 scale

次要结局

未报告次要终点

研究者

发起方

Aciex Therapeutics, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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