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

NCT ID: NCT02199964

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cyclosporin 0.05% emulsion

used in the eye 4 times a day

Group Type: EXPERIMENTAL

Cyclosporin 0.05% emulsion

Intervention Type: DRUG

Topical therapy for dry eye

Endura Refresh, Artificial Tears

Over the Counter artificial tears used in the eye 4 times a day

Group Type: ACTIVE_COMPARATOR

Endura, Refresh artificial tears

Intervention Type: DRUG

Over the counter therapy for dry eye, used 4 times a day

Interventions

Cyclosporin 0.05% emulsion

Topical therapy for dry eye

Intervention Type: DRUG

Endura, Refresh artificial tears

Over the counter therapy for dry eye, used 4 times a day

Intervention Type: DRUG

Other Intervention Names

Artificial tears; Cyclosporin 0.05% emulsion (Restasis); Dry Eyes; Dry Eyes; Artificial Tears

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Steven Pflugfelder

Director of Ocular Surface Clinical Trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen C. Pflugfelder, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine, Department of Ophthalmology

Locations

Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23572103 (View on PubMed)

Other Identifiers

H-33276

Identifier Type: -

Identifier Source: org_study_id