A Prospective, Randomized, Double-blinded, Multi-centric, Two-arm, Parallel-group, Active-Controlled, Phase III Study to Assess the Efficacy and Safety of Cetirizine Ophthalmic in Patients having ocular itching associated with allergic conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 8
- 主要终点
- Change in Ocular Itching Severity Score from baseline
研究概览
简要总结
This will be a Prospective, Randomized, Double-blinded, Multi-centric, Two-arm, Parallel group, Active-Controlled, Phase III Study. The study will be conducted at approximately 06-08 centers in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and EC approval. Adult subjects between 18 to 75 years of age, who are suffering from with allergic conjunctivitis are eligible for this study. Total 230 subjects suffering from above indication will be randomized to any of the two treatment arms. Efficacy Parameters: Change in Ocular Itching Severity Score from baseline. Change in Conjunctival Hyperemia Grade from baseline. Safety Parameters: Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Aged between 18 years to 75 years of both gender 2 Patient with signs and symptoms of allergic conjunctivitis diagnosed clinically 3 Subjects must have an ocular itching score 0 4 Patient is willing to give informed consent able to provide availability for the entire study period and follow study protocol.
排除标准
- •Patients with bacterial chlamydial viral and membranous conjunctivitis Patients with ocular surface disorders like pterygium dry eye were excluded from the study.
- •Patients with history of uveitis blepharitis herpes simplex keratitis or herpes zoster keratitis.
- •Patients with history of retinal detachment diabetic retinopathy and progressive retinal disease Patients with history of glaucoma or Intraocular Pressure over 25mmHg at the screening visit, or a history of elevated IOP within the past 1year.
- •Patients with ocular surgery or refractory surgery within 6 months prior to visit 1 or planning to do a surgery during the trial.
- •Patients with use of antibiotics, antivirals, or topical cyclosporine, depot corticosteroids, NSAIDS and other antihistamines or mast cell stabilisers within 1 month of the screening visit.
- •Patients unwilling not to wear contact lenses during the study.
- •Pregnant and lactating women Patient with history of hereditary degenerative retinal disorders eg retinitis pigmentosa or ischemic optic neuropathy including nonarteritic anterior ischemic optic neuropathy Patient with history of bleeding disorders or significant active peptic ulceration Patient with history of cancer or undergoing cancer chemo or radiotherapy Patient having hypersensitivity or any other contraindication to any of the Investigational products including its components; or history of hypersensitivity reaction to sulfa drugs Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study Investigator, study personnel, sponsor representatives and their first-degree relatives.
结局指标
主要结局
Change in Ocular Itching Severity Score from baseline
时间窗: Time frame: Day 1 3rd Minute, | Day 1 5th Minute, Day 1 7th Minute, Day 2, Day 7 and Day 14
次要结局
- Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study(Time frame: Screening, Day 2, Day 7 & Day 14)
研究者
Dr Sandeep Patil
Belagavi Institute of Medical Science