An observational analysis of clinical outcomes in patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Resolution of signs and symptoms in patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers.
研究概览
简要总结
Patients of vernal keratoconjunctivitis on their 1st visit(baseline,day 0) will be asked to sign the informed consent.Demographic information,clinical history &specific symptoms will be noted down.A complete ophthalmic evaluation comprising visual acuity(snellen chart),Slit lamp biomicroscopy, intra ocular pressure (IOP) and fundoscopy under pupillary dilatation will be done.. Patients fulfilling eligibility criteria will be included in the study.Patients on their first visit (DAY 0) will be examined and all the symptoms and signs will be recorded on the proforma.
All the above parameters will be reassessed on Day 14(visit 2) and Day 28(visit 3) after treatment with dual acting antihistamines and mast cell stabilisers.
All these visits are as per standard of care of the patient.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with a clinical diagnosis of vernal keratoconjunctivitis.
- •patients of either gender > 5 years.
- •patients should be willing to consent for all required study visits and follow instructions from study investigators.
排除标准
- •Patients who are in active stage of any other ocular inflammatory disease besides VKC Presence of glaucoma, uveitis.
- •Patients on any oral or topical steroids.
- •Pregnant or lactating women.
- •Presence of systemic diseases other than co existing allergic rhinitis, asthma and atopic dermatitis Any documented H/O hypersensitivity to the said drugs.
结局指标
主要结局
Resolution of signs and symptoms in patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers.
时间窗: 4 weeks
次要结局
- Resolution of signs and symptoms in patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers.(2 Weeks)