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NCT Number: NCT07816224

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in 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

    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.

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Sponsors and collaborators

Lead sponsor

Rehan Ahmed

Other

Registry information

Official study title

A Randomized, Double-Masked, Vehicle-Controlled, Two-Period Crossover Study of Atropine Sulfate Ophthalmic Solution (0.005% w/v) for the Treatment of Symptoms of Epiphora

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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