CTRI/2015/01/005399已完成3 期
A Clinical Trial to Study the Efficacy, Safety and Tolerability of Bepotastine Besilate Ophthalmic SolutionVs. Olopatadine Hydrochloride Ophthalmic Solution in Subjects Suffering from Allergic Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- To evaluate the efficacy of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis.
研究概览
简要总结
This study is a Comparative, Randomized, Double blind, Parallel group and Non Crossover Multicentric Clinical Study with Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis.
Ocular allergies are very common and range in intensity from mild, self-resolving, acute conditions to serious, chronic disease that can severely affect vision.
The efficacy parameter is primarilyfocused on ocular itching,conjuctival redness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject with sign and symptoms of allergic conjunctivitis like ocular itching, eye lid swelling, tearing, photophobia, watery discharge, diagnosis of allergic conjunctivitis will be confirmed by conjunctival smear examination.
- •2.Freshly diagnosed subject or Subjects who are previously diagnosed and on treatment of allergic conjunctivitis will undergo for 3 days wash out period 3.Subject willing to sign informed consent form (ICF) prior to any screening procedure.
- •For Minor subject (age below 18yrs) LAR (Legally Acceptable Representative) should be taken with assent.
排除标准
- •1.Subjects who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs.
- •2.Use of disallowed medications during the period indicated prior to study enrollment or during the study.
- •3.Subject with dry eyes should be excluded from the trial 4.Subject with Schirmer 10 should be excluded from the study.
- •5.Subject who are blind or subject with single eye.
- •6.Subjects who have planned surgery during trial period.
- •7.Subject with Vernal Keratoconjunctivitis should be excluded from the trial.
- •8.Subjects having corneal epithelial detachment or corneal ulcer in the target eye.
- •9.Subjects who are required to wear contact lens during the study period.
- •10.Subjects who are pregnant or may be pregnant or lactating.
- •11.Subjects who have participated in other clinical studies within 3 months.
- •13.Known contraindications or sensitivities to the study medication or its components.
- •14.Other patients who in the opinion of the investigator/sub investigator were inappropriate for the study participation.
结局指标
主要结局
To evaluate the efficacy of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution in Subjects Suffering from Allergic Conjunctivitis.
时间窗: Day 0,1 week,2 week and 3 week.
次要结局
- To evaluate the safety and tolerability of Bepotastine besilate ophthalmic solution Vs. Olopatadine hydrochloride ophthalmic solution.(Global assessment of study medications by Subjects and Investigators.)
研究者
研究点 (12)
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