Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops

March 3, 2008 updated by: National Eye Institute (NEI)

A Double-Masked, Randomized, Vehicle-Controlled Pilot Study of the Treatment of Keratoconjunctivitis Sicca With Topical Cyclosporin A 0.1% Emulsion

This study will examine whether cyclosporin A eye drops alleviate dry eye syndrome, a disorder of tear deficiency or excessive tear evaporation. The condition damages the surface of the eye and causes discomfort.

Age-related dry eye syndrome may result from a problem with the immune system in which cells called lymphocytes infiltrate the tear glands and cause a chronic, progressive inflammatory process. Previous studies suggest that cyclosporin A may increase tear production or decrease inflammation on the surface of the eye, or both, improving dry eye symptoms.

Patients in the study will undergo a complete eye examination, and a small tear sample will be collected to study tear consistency and composition. A small amount of conjunctiva (the clear, thin covering of the eye lining the eyelids and eyeball) will be removed to study substances in it that might provide information on what causes dry eye. A blood sample also will be taken to look for antibodies found in patients with Sjogren's syndrome, a disorder characterized by dryness of the mouth, eyes and other mucous membranes. Patients will also fill out forms providing information on the extent to which their dry eyes bother them.

Patients will be randomly divided into two treatment groups: one will take a cyclosporin 0.1% eye drop emulsion; the other will take the emulsion vehicle alone-that is, the same drops but without the active ingredient cyclosporin. Both groups will take one drop in each eye 4 times a day for 2 months. Neither the patients nor the doctors will know which patients are receiving which medication until the study ends. All patients will also be given artificial teardrops to use for comfort if needed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dry eye syndrome, also known as keratoconjunctivitis sicca or KCS, is a disorder of the tear film leading to damage to the ocular surface and ocular discomfort. In aqueous tear deficient dry eye, there is inadequate tear production. Patients with dry eye include those who have KCS and those with a more severe form of KCS associated with Sjogren's Syndrome (SS). In SS, lymphocytic infiltration of the lacrimal gland leads to destruction of acinar structures and impaired glandular function. Although most cases of KCS are not due to Sjogren's Syndrome, lymphocytic infiltration of the lacrimal glands of non-Sjogren's KCS patients has been demonstrated and some authors suggest that age-related atrophic changes of the lacrimal gland may be secondary to a chronic progressive inflammatory process. Several clinical studies have indicated that systemic or topical CsA improves some objective or subjective signs of KCS in patients with or without SS. In this protocol, patients with aqueous tear deficient KCS will be randomized to treatment with topical CsA 0.1% or the emulsion vehicle. To determine the safety and efficacy of CsA 0.1% treatment in patients with KCS, comprehensive ophthalmologic examinations and standardized symptom assessments will be performed. In addition, to determine the ability of topical CSA to alter ocular surface inflammation, pre- and post-treatment conjunctival biopsy specimens will be analyzed for infiltrating lymphocytes.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Eye Institute (NEI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Diagnosis of CS with documented symptoms and signs (as required below) despite conventional management which may include artificial tears, gels and ointments, sympathomimetic agents and parasympathomimetic agents:

Schirmer (without anesthesia) less than or equal to 8 mm/5 min in at least one eye; HOWEVER, if Schirmer (without anesthesia) is zero (0) mm, Schirmer with nasal stimulation greater than or equal to 3 mm/ 5 min in the same eye, OR;

Schirmer (with anesthesia) less than or equal to 10 mm/ 5 min in at least one eye and sum of interpalpebral staining greater than or equal to 3+ or corneal staining greater than or equal to 1+ in the same eye.

Able and willing to provide informed consent.

Willingness and ability to meet followup requirements.

Female patients of childbearing potential must use reliable forms of contraception during the study.

A negative pregnancy test result in women of childbearing potential.

Normal lid position and closure.

The following topical (creams, ointments or patches) or systemic medications are allowed as long as the patient has been on a stable dose for at least 90 days before the baseline visit: Estrogen-progesterone, or other estrogen derivatives.

If using concomitant medications, and the patient's condition is stable, the patient must agree to remain on a stable dose of his or her concomitant medications throughout the study period, or if the patient's condition is not stable, then they must agree not to use concomitant medications.

Review of the instructions for use of concomitant medications during the study, prior to the eye examination, and agreement from the patient that they will comply with the instructions. A copy of the instructions must be given to the patient prior to enrollment.

Patient must not have uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurologic disease, cancer, AIDS, or cerebral dysfunction) that could, in the judgment of the investigator, interfere with interpretation of the study results.

Patients must not have used ophthalmic topical or systemic cyclosporine in the past 90 days.

Patients must not have Schirmer readings less than 3 mm/5 min, without anesthesia, in both eyes after stimulation thereby indicating end stage lacrimal gland disease.

Patient must not have active ocular infection or non-KCS ocular inflammation.

Patient must not have a history of recurrent herpes keratitis or active disease within the last six months.

Patient must not have corneal disorder or abnormality that effects corneal sensitivity or normal spreading of the tear film (except SPK).

Patient must not have severe blepharitis or obvious inflammation of the lid margin which in the judgment of the investigator may interfere with the interpretation of the study results.

No plug placement (laser, cautery, silicone, or collagen implant) within one month prior to the screening visit.

No punctal occlusion performed during the study.

Patient must not have a history of anterior segment surgery or trauma which could affect corneal sensitivity (e.g., cataract surgery or any surgery involving a limbal or corneal incision within the last 12 months).

Patient must not have KCS secondary to the destruction of conjunctival goblet cells as occurs with vitamin A deficiency or scarring such as that with cicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation.

Patients must not use Saligan or antihistamines more than 3 times a week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1997

Study Completion

October 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

October 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980032
  • 98-EI-0032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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