Atropine Eye Drops for Watery Eyes (Excessive Tearing)

A Randomized, Double-Masked, Dose-Ranging Study of Atropine Sulfate Ophthalmic Solution for the Treatment of Symptoms of Epiphora

The goal of this clinical trial is to learn if low-dose atropine eye drops work to reduce excessive watery eyes (epiphora) in adults. It will also learn about the safety of the eye drops.

The main questions it aims to answer are:

Do the eye drops reduce how often participants have watery eyes? What medical problems do participants have when taking the eye drops?

Researchers will compare two strengths of the eye drops (0.005% and 0.01%) to see whether one works better than the other and whether the lower strength works as well as the higher one.

Participants will:

• Use the assigned eye drops in the affected eye(s) for one week
• Visit the clinic twice for checkups and eye tests
• Receive a follow-up phone call about two weeks after starting, to check on any symptoms

Study Overview

• Status: Recruiting
• Conditions: Epiphora
• Intervention / Treatment: Drug: Atropine ophthalmic solution

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rehan Ahmed; Phone Number: 713-661-6500; Email: studytearing@gmail.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77098
      • Recruiting
      • Greater Houston Eye Consultants
      • Contact: Rehan Ahmed, MD; Phone Number: 7136616500; Email: studytearing@gmail.com
    • Mesquite, Texas, United States, 75150
      • Recruiting
      • North Texas Eye Specialists
      • Contact: Rehan Ahmed, MD; Phone Number: 972-807-5744; Email: studytearing@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

You may be able to join if you:

• Are 18 years or older
• Have vision of 20/200 or better in at least one eye
• Have watery eyes (epiphora) bad enough to need wiping or dabbing at least twice a day
• Have watering caused by a functional/idiopathic, gustatory ("crocodile tears"), environmentally triggered (reflex), or obstructive cause - in one or both eyes
• Have a healthy eye surface, with no significant dry eye, active eye infection, or active eye inflammation
• Have adequate eyelid position and tone, where surgery is not the main treatment needed and reducing tear production is likely to help
• Are willing and able to put drops in your eye(s) once each night for 7 days and attend the study visits
• Can understand and follow the study procedures and communicate with study staff (an interpreter is allowed)

You will not be able to join if you:

• Have significant dry eye disease
• Have had an active eye infection within the past 30 days
• Have an active tear-sac infection, or a blocked tear duct that needs urgent surgery (a blocked tear duct that does not need surgery is allowed)
• Currently use eye drops that affect tear production or eye-surface testing, unless you are willing to stop them for the study
• Are allergic to, or should not take, atropine, similar (anticholinergic) medicines, or any ingredient in the study drops
• Have narrow-angle or angle-closure glaucoma, where dilating the pupil would not be safe for you
• Are pregnant or breastfeeding
• Are taking part in another interventional study, or took part in one within 30 days before screening
• Have any condition that, in the doctor's judgment, would make it unsafe for you to join or hard to follow the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atropine ophthalmic solution 0.005%	Drug: Atropine ophthalmic solution; The interventions are two low doses of atropine ophthalmic solution
Experimental: Atropine ophthalmic solution 0.01%	Drug: Atropine ophthalmic solution; The interventions are two low doses of atropine ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Munk Score Change	Proportion of subjects achieving a clinically meaningful Munk responder response (reduction of ≥2 Munk grades from baseline to Visit 2)	Time Frame: From enrollment to the end of treatment at 1 week

Collaborators and Investigators

• Sponsor: Rehan Ahmed

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases
• Other Study ID Numbers: IND-180375-P2-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No