Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Ophthalmic Solutions; Tacrolimus; Tetrahydrozoline

Criteria

Inclusion Criteria:

• SS was diagnosed according to the SS European Criteria

• chronic symptoms of burning, foreign body sensation, itching in both eyes

• daily need of artificial tears

• abnormal Schirmer (ST) I test < 5mm or rose Bengal staining (RBS) ≥ 4, or break up time (BUT) < 5 seconds.

Exclusion Criteria:

• any structural abnormalities (lid scarring, entropion, trichiasis, etc.)

• any inflammation or active structural change in the iris or anterior chamber

• glaucoma

• previous eye surgery or punctual occlusion

• use of any other topical medication other than artificial tears

• any systemic or topical antibacterial or antiinflammatory drug treatment 90 days before study entry

• contact lens wearer

• the presence of any corneal infection

• any corneal diseases (marginal ulcer, opacity, scar, bullous keratopathy, conjunctivochalasis, symblepharon or tumor)

• pregnancy

• change in the immunosuppressive systemic therapy 90 days before study entry