An Early Phase 1 interventional study of Pilocarpine Ophthalmic Solution in Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Maastricht University Medical Center · Early Phase 1, Interventional, and Supportive care
The investigators intended for this study to deliver the "proof-of-concept" that locally administered pilocarpine drops in two doses are effective in a population of elderly (aged ≥ 70 years) with xerostomia at the expense of limited adverse events. To this end, the study aims to quantify the effect size of pilocarpine in two different dosages. In case the investigators observe clinically meaningful changes in xerostomia through measured NRS, a sufficiently-powered RCT will be prepared to compare pilocarpine to placebo.
254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.
This study's enrollment of 14 is below the median of 42 across 216 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
Drug: Pilocarpine Ophthalmic Solution
high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
Drug: Pilocarpine Ophthalmic Solution
1. low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day 2. high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
Change in xerostomia score (Numeric Rating Scale)
The Numeric Rating Scale is used to quantify the level of severity of xerostomia using a 0-10 cm Numeric Rating Scale ranging from 0 = no dry mouth to 10 = worst possible dry mouth
Time frame: 3 weeks
Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index)
Questionnaires assessing Oral health-related quality of life of adults, in particular older people is measured 4 times during this study by the doctor/research nurse . It comprises 12 items that measure three dimensions of Oral health-related quality of life: physical function items, psychosocial function and pain/discomfort.
Time frame: 2 weeks
Adverse effects
adverse events or other symptoms
Time frame: 3 weeks
Global perceived effect
The Global perceived effect scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point.
Time frame: 3 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center