Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Allergan
• Treatments: Castor Oil; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Patients diagnosed for mild to moderate Aqueous Deficient DED (ADDED), defined as Schirmer 1 < 10mm;

• Patients diagnosed for mild to moderate Evaporative DED (EDED), defined as normal Schirmer 1 and BUT < 5 seconds;

• Patients submitted to refractive surgery,

• Patients capable of understanding instructions, signing the term of consent and available to attend all exam visits.

Exclusion Criteria:

• patients with punctual occlusion,

• active ocular infection or inflammatory disease,

• history of herpetic keratitis,

• contact lens use during trial period,

• patients with glaucoma,

• any eyelid globe malposition abnormality.