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

NCT07816224 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IND-180375-P2B-001
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epiphora

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

Atropine then vehicle

EXPERIMENTAL

Atropine then vehicle - Description: Atropine 0.005% nightly for 7 days, approximately 14-day washout, then vehicle nightly for 7 days.

Drug: Atropine sulfate ophthalmic solution 0.005%; Drug: Vehicle arm

Vehicle then atropine

EXPERIMENTAL

Vehicle then atropine - Description: Vehicle nightly for 7 days, approximately 14-day washout, then atropine 0.005% nightly for 7 days.

Drug: Atropine sulfate ophthalmic solution 0.005%; Drug: Vehicle arm

Interventions

Atropine sulfate ophthalmic solution 0.005% DRUG

One drop in the affected eye(s) once nightly at bedtime for 7 days.

Atropine then vehicle; Vehicle then atropine

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

Atropine then vehicle; Vehicle then atropine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rehan Ahmed: lead

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Rehan Ahmed, MD

CONTACT

studytearing@gmail.com; studytearing@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share