Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tear Film Break-up Time (TBUT)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
详细描述
A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
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
- •Patients with diagnosis of mild-to-moderate drye eye syndrome.
- •Male or female patients.
- •Patients 18 years of age
排除标准
- •Patients with one blind eye.
- •Visual acuity of 20/40 in any eye
- •Patients with history of active stage of any other concomitant ocular disease.
- •Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present.
- •Contraindications or sensitivity to any component of the study treatments.
- •Ocular surgery within the past 3 months.
- •Contact lens users.
- •Females of childbearing potential )may not participate in the study if any of the following conditions exist:
- •They are pregnant,
- •They are breastfeeding,
- •They have a positive urine pregnancy test at screening,
- •They intend to become pregnant during the study, or
- •They do not agree to use adequate birth control methods for the duration of the study.
- •Participation in any studies of investigational drugs within 90 days previous to the inclusion.
- •Discontinuation criteria:
- •Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
研究组 & 干预措施
PRO-148 Ophthalmic Solution
Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days
干预措施: PRO-148 Ophthalmic Solution (Drug)
结局指标
主要结局
Tear Film Break-up Time (TBUT)
时间窗: During 60 days
TBUT was evaluated at baseline and end of the study
次要结局
- Presence of Adverse Events(60 days)