Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops
Status:
Completed
Trial end date:
2000-10-01
Target enrollment:
Participant gender:
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.