Epiphora
Conditions
Brief summary
This study tests whether a very low concentration of atropine eye drops (0.005%) reduces excessive tearing (epiphora) in adults. Each participant will use two different eye drops, one at a time: the atropine drop and an identical-looking drop with no active ingredient (vehicle). Each drop is used once nightly for 7 days, with about 2 weeks between the two treatment periods. Neither the participant nor the study doctor will know which drop is being used during each period. The main measure is the change in how often participants need to wipe their eyes because of tearing. About 12 to 18 adults will take part.
Interventions
DRUGAtropine sulfate ophthalmic solution 0.005%
One drop in the affected eye(s) once nightly at bedtime for 7 days.
DRUGVehicle arm
Identical-appearing drops without atropine; one drop in the affected eye(s) once nightly at bedtime for 7 days. - Other name: Placebo
Sponsors
Rehan Ahmed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years of age or older * Symptomatic epiphora (unilateral or bilateral) with tearing requiring eyelid wiping or dabbing at least 2 times per day (Munk score ≥2) * Epiphora attributed to functional/idiopathic, gustatory, environmental, or lacrimal outflow (e.g., nasolacrimal duct obstruction, punctal stenosis) etiology * Visual acuity of 20/200 or better in at least one eye (with habitual correction or pinhole) * Willing and able to self-administer eye drops nightly for 7 days in each of two treatment periods and attend all study visits * Prior use of topical atropine permitted if at least 10 days have elapsed since the last dose
Exclusion criteria
* Clinically significant dry eye disease, or tearing judged to be a reflex response to ocular surface disease, blepharitis, or other ocular surface irritation * Regular use of artificial tears, ocular lubricants, or dry eye medications, or unwillingness to stop them during the study * Active or recent (within 30 days) ocular infection, or active dacryocystitis * Current use of ophthalmic anticholinergic agents (unless stopped at least 10 days before Visit 1) * Hypersensitivity to atropine, other anticholinergics, or any component of the formulation * Angle-closure glaucoma or narrow anterior chamber angles * Pregnancy or breastfeeding * Participation in another interventional study within 30 days * Any condition or medication that, in the investigator's judgment, would interfere with study assessments or subject safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tearing | Period baseline (Day 1) to Day 7 of each 7-day treatment period, assessed at the end-of-period visit (Day 8 ±2); approximately 4 weeks overall | Within-participant difference (atropine minus vehicle) in change in Munk epiphora score from period baseline to Day 7 of each treatment period. Munk score range 0-4; higher scores indicate more frequent tearing. |
Contacts
CONTACTRehan Ahmed, MD
Outcome results
None listed