Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to access the possible beneficial effects of oral use of pilocarpine in relieving signs and symptoms of patients with Sjogren's syndrome

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Pilocarpine

Criteria

Inclusion Criteria:

• Patients with Sjögren's syndrome, both in primary and secondary forms, whose diagnoses were established according to the criteria defined by the - American-European Consensus for the diagnosis of Sjögren's syndrome.

• Patients with the secondary form of the syndrome, collagen disease considered controlled by a rheumatologist, before the start of the trial and stable until the end of the study.

• Systemic therapy instituted up to two months before the beginning of the protocol.

• Literate patients.

• Signature of the informed consent form

Exclusion Criteria:

• Eye or eyelid surface disease not attributed to Sjogren's syndrome.

• Temporary or permanent occlusion of tear points.

• Use of contact lenses.

• Use of systemic medication that is known to influence tear flow.

• Need to modify the systemic treatment of the underlying disease during the trial.

• Pregnancy or breastfeeding.

• Known hypersensitivity reaction to pilocarpine hydrochloride.

• Severe cardio-pulmonary disease.