Comparative evaluation of combined treatment using 0.03% chloroquine phosphate and 0.1% olopatadine eye drops with monotherapy using 0.1% olopatadine eye drops in patients with allergic conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduction in ocular symptoms including eye itching and rubbing
研究概览
简要总结
Allergic eye disease is an important cause of ocular morbidity in young healthy individuals. Adequate control of disease requires long term use of corticosteroids in combination with other anti-allergics. Effective control of allergy is important since many of these patients have underlying co-morbidities such as keratoconus and are contact lens users. Topical agents with effective ant-inflammatory properties but without any adverse effects will help avoid the long term use of corticosteroids in these patients.
This randomized study aims to compare a newer drug named chloroquine, with established anti-inflammatory properties for the management of cases with allergic conjunctivitis. The study will be conducted as a placebo controlled trial involving 200 subjects over a period of 3 years. Adequate control of symptoms will be considered as the primary outcome measure and changes in tear film inflammatory markers will be considered as the secondary outcome measure. The patients will be given treatment for a period of 1 year. Evaluation of parameters will be done at 1 week, 4 weeks, 2 months, 3 months, 6 months, 9 months and at 1 year follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients attending the outpatient department with clinically diagnosed allergic eye disease based on signs (itching, watering) and symptoms (conjunctival hyperemia, palpebral hypertrophy) will participate in the study.
- •No other methods of diagnosis will be considered besides clinical signs and symptoms.
排除标准
- •1.Uveitis, conjunctivitis and other ocular pathologies 2.Bronchial asthma, eczema 3.History of dry eye, blepharitis, contact lens use 4.Receiving topical or systemic medications 5.History of sensitivity to any constituents of the eye drops.
结局指标
主要结局
Reduction in ocular symptoms including eye itching and rubbing
时间窗: 1 week, 4 weeks, 2 months, 3 months, 6 months, 9 months, 1 year
次要结局
- Alterations in Inflammatory markers in tear film(Alpha- Antitrypsin, MMP9, IL-1, IL-8, IFN gamma)(4 weeks, 3 months, 6 months, 9 months, 1 year)