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

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

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

After being informed about the study, its potential risks and having signed the informed consent form, this placebo-controlled, crossover study involved patients with Sjögren's syndrome to use oral pilocarpine or placebo for ten weeks and after two weeks of medication withdrawal, to invert the treatment for the same period of time. The assessments applied were the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time, traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and rose bengal dyes, Schirmer test, and tear ferning test. Side effects observed during the treatment period were also assessed.

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.