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

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Dry Eye

Treatments: Drug: Pilocarpine Hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04470479

0910/03

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Pilocarpine Hydrochloride

Experimental group

Description:

Patients with Sjögren's syndrome were allocated to receive oral pilocarpine 20mg per day, (5mg every 6 hours, for ten weeks.

Treatment:

Drug: Pilocarpine Hydrochloride

placebo

Placebo Comparator group

Description:

Patients with Sjögren's syndrome were allocated to receive placebo administered in the same way (1 tablet every 6 hours), for ten weeks

Treatment:

Drug: Placebo