Clinical trial NCT04470479: Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome
Official title: Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Keywords: dry eye
Sjogren
pilocarpine hydrochloride
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This was a placebo-controlled, crossover study that involved patients with Sjögren's syndrome to use 20mg/day of 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, tear ferning test, osmolarity and the activity of lysozyme. R
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in the Ocular Surface Disease Index questionnaire at week 10
timeFrame: Baseline and week 10
measure: Change from baseline Ocular Surface Disease Index questionnaire at week 22
timeFrame: Baseline and week 22
measure: Change from baseline in the NEI-VFQ-25 questionnaire at week 10
timeFrame: Baseline and week 10
measure: Change from baseline in the NEI-VFQ-25 questionnaire at week 22
timeFrame: Baseline and week 22
measure: Change from baseline in tear breakup time test at week 10
timeFrame: Baseline and week 10
measure: Change from baseline in tear breakup time test at week 22
timeFrame: Baseline and week 22
measure: Change from baseline in score with rose bengal staining at week 10
timeFrame: Baseline and week 10
measure: Change from baseline in score with rose bengal staining at week 22
timeFrame: Baseline and week 22
measure: Change from baseline in corneal keratitis score with fluorescein dye at week 10
timeFrame: Baseline and week 10
measure: Change from baseline in corneal keratitis score with fluorescein dye at week 22
timeFrame: Baseline and week 22
measure: Change from baseline in The Schirmer test at week 10
timeFrame: Baseline and week 10
measure: Change from baseline in The Schirmer test at week 22
timeFrame: Baseline and week 22
measure: Change from baseline in Tear ferning test (Rolando'score) at week 10
timeFrame: Baseline and week 10
measure: Change from baseline in Tear ferning test (Rolando'score) at week 22
timeFrame: Baseline and week 22
Secondary outcomes:
measure: The frequency of systemic side effects most frequently reported by patients at week 10
timeFrame: week 10
measure: The frequency of systemic side effects most frequently reported by patients at week 22
timeFrame: week 22
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Irmandade Santa casa de Misericórdia de São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Sergio Felberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.