The Effects of Cyclosporin A Emulsion, (Restasis), on the Ocular Surface in Response to Low Humidity Environment in Patients With Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Corneal Fluorescein Staining
研究概览
简要总结
This study will test that hypothesis that topical administration of the FDA approved immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface disease that results from a short term low humidity environmental stress
详细描述
This is a pilot study designed to evaluate the effect of two conventional dry eye therapies, artificial tears to hydrate and cyclosporine A as an anti-inflammatory, on the irritation symptoms and ocular surface disease of dry eye patients who will be exposed to a low humidity environment for 90 minutes. Patients with dry eye will be enrolled in this study and complete a validated symptom questionnaire and then undergo a complete ocular surface and tear examination to characterize their disease. Enrolled subjects will be exposed to a low humidity environment at the initial evaluation prior to any treatment and will be exposed to a low humidity environment for a second time. They will be randomized to receive either artificial tears or 0.05% cyclosporine A emulsion drop four times a day for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature on the written informed consent form
- •Patient willingness and ability to return for all visits during the study
- •Rapid tear film break up time of seven seconds or less in at least one eye AND
- •Both cornea fluorescein staining score greater than or equal to 3 and conjunctival lissamine green staining greater than or equal to 3 in at least one eye
- •Ocular Surface Disease Index Symptom Severity score of twenty or greater
- •Tear meniscus height less than or equal to 230um
- •Intact corneal sensitivity
- •Willingness to discontinue use of any current dry eye treatment (except artificial tears) for four weeks prior to enrollment, and during the course of the study
排除标准
- •Compromised cognitive ability which may be expected to interfere with study compliance
- •Uncontrolled or poorly controlled diabetes or heart or pulmonary disease that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study
- •Known hypersensitivity to any components of the artificial tears or cyclosporin A eye drops Anticipated contact lens wear during the study
- •History of corneal transplant
- •Active ocular infection, uveitis or non-KCS related inflammation
- •History of cataract surgery within 3 months prior to enrollment
- •History of pterygium removal within 6 months prior to enrollment
- •Reduced corneal sensitivity
- •Initiation, discontinuation or change in dosage of hormone replacement therapy (HRT), fish oil, evening primrose, flaxseed, or black current seed oil supplements, antihistamines, cholinergic agents, beta-blocking agents, tricyclic or SSRI antidepressants, phenothiazines, or topical or systemic acne rosacea medications in two months prior to enrollment, or anticipated change in dosage during course of study
- •Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during the study (except artificial tears)
- •Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal plugs within three months prior to study, or anticipated use of same during study
研究组 & 干预措施
Cyclosporin 0.05% emulsion
used in the eye 4 times a day
干预措施: Cyclosporin 0.05% emulsion (Drug)
Endura Refresh, Artificial Tears
Over the Counter artificial tears used in the eye 4 times a day
干预措施: Endura, Refresh artificial tears (Drug)
结局指标
主要结局
Corneal Fluorescein Staining
时间窗: 6 weeks
The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42
次要结局
- Eye Irritation Symptoms(6 weeks)
研究者
Steven Pflugfelder
Director of Ocular Surface Clinical Trials
Baylor College of Medicine