Low-Dose Atropine Eye Drops for Excessive Tearing (Epiphora)

ConditionEpiphora

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorRehan Ahmed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

Atropine sulfate ophthalmic solution 0.005%
Drug
One drop in the affected eye(s) once nightly at bedtime for 7 days.
Vehicle arm
Drug
Identical-appearing drops without atropine; one drop in the affected eye(s) once nightly at bedtime for 7 days. - Other name: Placebo

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: Atropine then vehicleExperimental treatment 2 interventions

Group B: Vehicle then atropineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in tearing

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.

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rehan Ahmed

Lead sponsor

Greater Houston Eye Consultants

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: