Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops

Sjogren's Syndrome Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome

• NCT number: NCT00001731
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 2
• Start date: November 1997
• Completion date: October 2000