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

Last updated: July 13, 2020
Sponsor: Federal University of São Paulo
Overall Status: Completed

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Dry Eye Disease

Eyelid Inflammation

Treatment

N/A

Clinical Study ID

NCT04470479
0910/03
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

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

  • Literate patients.

  • Signature of the informed consent form

Exclusion

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.

Study Design

Total Participants: 32
Study Start date:
March 01, 2005
Estimated Completion Date:
April 01, 2006

Study 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.

Connect with a study center

  • Irmandade Santa casa de Misericórdia de São Paulo

    São Paulo, 01221010
    Brazil

    Site Not Available

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