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

NCT ID: NCT04470479

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-01
• Study Completion Date: 2006-04-01

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pilocarpine Hydrochloride

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

Group Type: EXPERIMENTAL

Pilocarpine Hydrochloride

Intervention Type: DRUG

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.

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Salagen

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Sergio Felberg

Posgraduate Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio Felberg, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Irmandade Santa casa de Misericórdia de São Paulo

São Paulo, , Brazil

Countries

Brazil

References

Kawakita T, Shimmura S, Tsubota K. Effect of Oral Pilocarpine in Treating Severe Dry Eye in Patients With Sjogren Syndrome. Asia Pac J Ophthalmol (Phila). 2015 Mar-Apr;4(2):101-5. doi: 10.1097/APO.0000000000000040.

Reference Type: RESULT

PMID: 26065354 (View on PubMed)

Cifuentes M, Del Barrio-Diaz P, Vera-Kellet C. Pilocarpine and artificial saliva for the treatment of xerostomia and xerophthalmia in Sjogren syndrome: a double-blind randomized controlled trial. Br J Dermatol. 2018 Nov;179(5):1056-1061. doi: 10.1111/bjd.16442. Epub 2018 May 29.

Reference Type: RESULT

PMID: 29432648 (View on PubMed)

Papas AS, Sherrer YS, Charney M, Golden HE, Medsger TA Jr, Walsh BT, Trivedi M, Goldlust B, Gallagher SC. Successful Treatment of Dry Mouth and Dry Eye Symptoms in Sjogren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77. doi: 10.1097/01.rhu.0000135553.08057.21.

Reference Type: RESULT

PMID: 17043506 (View on PubMed)

Other Identifiers

0910/03

Identifier Type: -

Identifier Source: org_study_id