Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Laboratoires Thea0 个研究点开始时间: 2002年10月最近更新: 2006年7月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Laboratoires Thea
主要终点: Ocular pharmacokinetic in tears

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

详细描述

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

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

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female aged from 18 to 45 years old;
•Written informed consent;
•Healthy volunteers without any subjective ocular symptom;
•Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);
•Registered, or agreed to be registered, in the national register of healthy volunteers

排除标准

•Ocular trauma, infection or inflammation within the last 3 months;
•number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
•number of corneal stained punctuations >= 5;
•blepharitis, conjunctivitis, uveitis;
•contact lenses;
•topical ocular treatment within the last month;
•ocular laser within the last 3 months;
•ocular surgery, including LASIK and PRK, within the last 12 months;
•systemic macrolide within the last month;
•medication during the study (except: paracetamol and contraceptives).

结局指标

主要结局

Ocular pharmacokinetic in tears

次要结局

Tolerance

研究者

发起方

Laboratoires Thea

申办方类型

Industry

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