CompletedPhase 3

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

Brazil32 participantsStarted 2005-03-01

Plain-language 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in the Ocular Surface Disease Index questionnaire at week 10

Timeframe: Baseline and week 10

Change from baseline Ocular Surface Disease Index questionnaire at week 22

Timeframe: Baseline and week 22

Change from baseline in the NEI-VFQ-25 questionnaire at week 10

Timeframe: Baseline and week 10

Change from baseline in the NEI-VFQ-25 questionnaire at week 22

Timeframe: Baseline and week 22

Change from baseline in tear breakup time test at week 10

Timeframe: Baseline and week 10

Change from baseline in tear breakup time test at week 22

Timeframe: Baseline and week 22

Change from baseline in score with rose bengal staining at week 10

Timeframe: Baseline and week 10

Trial details

NCT IDNCT04470479

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-04-01

View on ClinicalTrials.gov More Dry Eye trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline in the Ocular Surface Disease Index questionnaire at week 10

Timeframe: Baseline and week 10

Change from baseline Ocular Surface Disease Index questionnaire at week 22

Timeframe: Baseline and week 22

Change from baseline in the NEI-VFQ-25 questionnaire at week 10

Timeframe: Baseline and week 10

Change from baseline in the NEI-VFQ-25 questionnaire at week 22

Timeframe: Baseline and week 22

Change from baseline in tear breakup time test at week 10

Timeframe: Baseline and week 10

Change from baseline in tear breakup time test at week 22

Timeframe: Baseline and week 22

Change from baseline in score with rose bengal staining at week 10

Timeframe: Baseline and week 10