Overview

Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops

Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune, chronic, inflammatory and systemic disease which affects most commonly the lacrimal and salivary glands.The ocular treatment is focused in increasing lubrification and decreasing inflammation with topical autologous serum, topical immunosuppressive agents and corticotherapy. Use of topical immunosuppressants has increased in recent years because the topical corticotherapy leads to ocular complications. The most used immunosuppressant is cyclosporine. Tacrolimus , another immunosuppressant, has been used in treatment of immune and inflammatory ocular diseases.This study describes a prospective controlled double-blinded randomized study of the clinical outcome of SS dry eyes patients treated with 0.03% tacrolimus eye drops. As secondary purposes, outcome of dry eye symptoms and any ocular symptoms of the eye drops were also questioned to the patients.
Phase:
Phase 4
Details
Lead Sponsor:
University of Sao Paulo General Hospital
Treatments:
Ophthalmic Solutions
Tacrolimus
Tetrahydrozoline