Status:
TERMINATED
The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Allergan
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ocul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02199964
Start Date
March 1 2014
End Date
December 1 2015
Last Update
February 20 2020
Active Locations (1)
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1
Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine
Houston, Texas, United States, 77030