NCT04470479

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Pilocarpine Hydrochloride	Oral pilocarpine hydrochloride 5mg tablets were administered four times a day for 10 weeks to half the group of selected patients. The other half ingested placebo in the same way. At the end of this period and after two weeks of washing out the medications, the patients had to invert the treatments.
DRUG	Placebo	Placebo

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2020-07-14
• Last updated: 2020-07-14

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study