A prospective three arm randomised pilot trial to evaluate the role of individualised Homoeopathy compared with Artificial Teardrops in managing mild to moderate dry eye disease DED.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index OSDI score
研究概览
简要总结
Dry eyes disease, also known as dry eye syndrome, or keratoconjunctivitis sicca (KCS), is a condition of insufficient moisture of eyes due to increased tear film evaporation or its decreased secretion leading to symptoms of ocular discomfort like excessive dryness, sensation of sand in eyes with gritty feeling, blurred vision, photophobia, redness of eyes with burning pains and overall eye discomfort.
Homoeopathy which follows the individualised approach, consider the signs and symptoms of the person before prescribing medicine, is known to have beneficial role in management of Ophthalmological conditions. Not much published studies on effectiveness of individualized Homoeopathic medicines in the treatment of DED is available. So, more definitive comparative studies are required to prove the same
The current study has been designed with Primary objective to compare the efficacy of individualized Homoeopathic medicine alone, and in combination of artificial tear drops with artificial tear drops only in relieving signs and symptoms of mild to moderate DED. To determine change in Ocular Surface Disease Index (OSDI) before and after treatment between the groups. Secondary objective being assessment of the change in Tear osmolarity and tear film break-up time between the study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patient aged 18 years or above.
- •Presenting with at least two of dry eye related symptoms, including itching, dryness, foreign body sensation, burning, blurred vision, photophobia, and soreness or pain etc in at least one of the eye.
- •Diagnosis of mild to moderate dry eye syndrome with or without Sjögrens syndrome.
- •Best corrected visual acuity 6/
- •Following results in at least one of the eye Ocular Surface Disease Index OSDI test symptoms between 12 and 33 Tear film break up time less than or equal to 10 seconds in atleast one of the eye.
- •Willing to follow the study schedule and provide written informed consent.
排除标准
- •1 Complaints of ocular comorbidity including non-dry eye ocular inflammation, severe blepharitis, glaucoma, contact lens allergy or any condition known to have effect on the study outcome.
- •2 History of any Trauma or eye surgery during last 3 months 3 Presenting with any uncontrolled systemic disease or significant illness and other autoimmune or connective tissue disorders such as rheumatoid arthritis and lupus, and thyroid disease.
- •4 Current use of topical ophthalmic medications that could affect dry eye syndrome and not willing to stop.
- •5 Pregnant &/or lactating female or considering a pregnancy.
结局指标
主要结局
Change in Ocular Surface Disease Index OSDI score
时间窗: Baseline, monthly for 06 months
Change in intensity of symptoms of dry eye disease on VAS self-assessment of ocular discomfort reported by participants
时间窗: Baseline, monthly for 06 months
次要结局
- -Change in tear film break-up time(-Change in Tear osmolarity)
研究者
Dr Deepti Singh
Central Council for Research in Homoeopathy