Clinical trial NCT02199964: The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface
Official title: The Effects of Cyclosporin A Emulsion, (Restasis), on the Ocular Surface in Response to Low Humidity Environment in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
environmental stress
artificial tears
cyclosporin
Restasis
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2014-07-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: 6 weeks
Secondary outcomes:
measure: Eye Irritation Symptoms
timeFrame: 6 weeks
Other outcomes:
measure: Conjunctival Goblet Cells
timeFrame: 6 weeks
Locations:
city: Houston
country: United States
facility: Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine, Department of Ophthalmology
name: Stephen C. Pflugfelder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alex A, Edwards A, Hays JD, Kerkstra M, Shih A, de Paiva CS, Pflugfelder SC. Factors predicting the ocular surface response to desiccating environmental stress. Invest Ophthalmol Vis Sci. 2013 May 7;54(5):3325-32. doi: 10.1167/iovs.12-11322.