The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface (CsA)

Baylor College of Medicine

Status

Terminated

Conditions

Dry Eye

Treatments

Drug: Cyclosporin 0.05% emulsion

Drug: Endura, Refresh artificial tears

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02199964

H-33276

Details and patient eligibility

About

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

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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