A Randomized,Open label ,Parallel comparative study of efficacy,safety and tolerability of ophthalmic solutions of Alcaftadine 0.25% and Olopatadine 0.1% in patients with Allergic conjunctivitis in a tertiary care center
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1)To compare the improvement in ocular symptoms and signs in patients with Allergic conjunctivitis after the treatment with the study drugs.
研究概览
简要总结
This study is a randomized, open label, parallel group , active controlled study comparing the safety, efficacy and tolerability of ophthalmic solutions of Alcaftadine 0.25% and Olopatadine 0.1% in patients with Allergic conjunctivitis in a tertiary care
The primary outcome measures will be improvement in ocular symptoms and signs and reduction in tear Ig E levels at the end of the 3 weeks.The secondary outcomes will be reduction in ocular symptoms and signs at 8th day and improvement in quality of life at the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients aged > 18 years of both genders clinically diagnosed with allergic conjunctivitis by ophthalmologists.
- •Graded conjunctival redness in at least one region (nasal or temporal) in Eye.
- •Graded ocular itching at any one time point 4)Visual acuity of at least 6/15 in each eye 5)All patients who had an attack history more than 2 years.
排除标准
- •Patients with bacterial, chlamydial, viral and membranous conjunctivitis were excluded 2)Patients with ocular surface disorders like pterygium, dry eye were excluded from the study.
- •Patients who have known hypersensitivity to the drug.
- •History of uveitis, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
- •History of retinal detachment, diabetic retinopathy and progressive retinal disease 6)History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
- •Ocular surgery or refractory surgery within 6 months prior to visit 1 or planning to do a surgery during the trial.
- •Use of antibiotics, antivirals, or topical cyclosporine, depot corticosteroids, NSAIDS and other antihistamines or mast cell stabilisers within 1 month of the screening visit.
- •Participants unwilling not to wear contact lenses during the study.
- •Pregnant and lactating women 11)Subjects must not have an ocular itching score >0 or a conjunctival hyperaemia score >1 in either eye in any region (nasal or temporal) at Visit 1.
结局指标
主要结局
1)To compare the improvement in ocular symptoms and signs in patients with Allergic conjunctivitis after the treatment with the study drugs.
时间窗: 3 weeks
2)To compare the reduction in levels of IgE in tear fluid in patients of Allergic Conjunctivitis after the treatment with both the drugs.
时间窗: 3 weeks
次要结局
- Change from baseline in mean of ocular itching and redness as assessed after 30 minutes of instillation of drops(Change from baseline in mean of ocular symptoms and signs on 8th day)