Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

Laboratoires Thea0 个研究点开始时间: 2002年3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 subjective symptoms

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 compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation

详细描述

The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

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 ocular symptom);
•Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - Slit lamp examination without clinical relevant abnormalities - Tear break-up time (BUT) ≥10 seconds - Lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - Lissamine green test total score < 4 +).

排除标准

•Ocular trauma, infection or inflammation within the last 3 months;
•Blepharitis;
•Conjunctival hyperaemia (score >= 2 +);
•Watering (score >= 2);
•Contact lenses;
•Ocular surgery, including LASIK and PRK, within the last 12 months;
•Topical ocular treatment within the last month;
•Systemic antibiotics within the last 7 days;
•Any medication during the study (except: Paracetamol and contraceptives).

结局指标

主要结局

Ocular subjective symptoms

Ocular objective symptoms

次要结局

Ocular pharmacokinetic.
Ocular and systemic adverse events.

研究者

发起方

Laboratoires Thea

申办方类型

Industry

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