Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI)
研究概览
简要总结
The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.
详细描述
Dry eye disease affects millions of people world-wide, and presents with symptoms of blurred vision, discharge from the eyes, eye discomfort, burning, redness, sandy and gritty feeling in the eyes, and sensitivity to light. Topical eye drops for eye lubrication (i.e., artificial tear solutions) and controlling ocular inflammation through the use of topical immunomodulatory agents (i.e., cyclosporine [Restasis]) have been shown to be effective for treating dry eye syndrome, but are not curative. Recently, we have evaluated a few patients who had discontinued using Restasis as they had obtained better relief of their dry eye symptoms with a homeopathic therapy.
Potential participants will undergo an eye examination consisting of medical history and physical examination (i.e., visual acuity, pupillary exam, examination of the lids, slit-lamp examination of the conjunctiva, cornea, anterior chamber, iris, and lens, and funduscopic examination). Participants qualifying for the study will then stop all eye medications and will use a common artificial tear solution for 2 weeks prior to the baseline examination. We will evaluate 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film to break-up; 2) staining of the cornea by fluorescein stain; 3) measurement of tear production over 5 minutes by Schirmer's test; and 4) the Ocular Surface Disease Index (OSDI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of moderate to severe dry eye syndrome with or without Sjögren's syndrome
- •receiving treatment with topical cyclosporine (Restasis)
- •experience one or more moderate dry eye-related symptoms, including dryness, foreign body sensation, burning, blurred vision, photophobia, and soreness or pain
排除标准
- •history of ocular disorder including non-dry eye ocular inflammation, glaucoma, contact lens use
- •trauma or surgery, including punctal plug insertion within the prior 3 months
- •any uncontrolled systemic disease or significant illness
- •use of topical ophthalmic medications that could affect dry eye syndrome
- •pregnancy, lactation, or considering a pregnancy
研究组 & 干预措施
Intervention
Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .
干预措施: Euphrasia-based homeopathic therapy (Drug)
Intervention
Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .
干预措施: Cyclosporin solution (Drug)
Control
Subjects will receive placebo in combination with cyclosporin solution (Restasis) .
干预措施: Cyclosporin solution (Drug)
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI)
时间窗: Start of treatment, 6 weeks
Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.
次要结局
- Change in Fluorescein Staining Scale(Baseline, 6 weeks)
- Change in Tear Film Breakup Time(Baseline, 6 weeks)
- Change in Schirmer Tear Test With Anesthesia Result(Baseline, 6 weeks)