Status:
COMPLETED
Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome
Lead Sponsor:
Federal University of São Paulo
Conditions:
Dry Eye
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 pi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04470479
Start Date
March 1 2005
End Date
April 1 2006
Last Update
July 14 2020
Active Locations (1)
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1
Irmandade Santa casa de Misericórdia de São Paulo
São Paulo, Brazil, 01221010