Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score
研究概览
简要总结
The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 12 years of age and older with 2-year history of allergic conjunctivitis
排除标准
- •No active ocular or nasal infection
研究组 & 干预措施
Bepotastine Besilate Ophthalmic Solution
干预措施: bepotastine besilate ophthalmic solution (Drug)
Placebo
干预措施: placebo comparator ophthalmic solution (Drug)
结局指标
主要结局
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score
时间窗: Baseline, 14 days
Responses to questions relating to symptoms and daily activities in the RQLQ were provided for 28 questions encompassing the 7 major domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional state. Each response to an RQLQ question was provided on a scale of 0-6 units, where 0 = not troubled/none of the time and 6 = extremely troubled/all of the time. The minimum total score was 0 units and the maximum total score was 42 units, with higher score indicating decreased quality of life due to rhinoconjunctivitis.
次要结局
- Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period(Baseline, 14 days)
- Global Therapeutic Response Rating - Investigator Assessed(14 days)
- Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period(Baseline, 14 days)
- Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period(Baseline, 14 days)
- Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period(Baseline, 14 days)
- Global Therapeutic Response Rating - Participant Assessed(14 days)