Recruiting
Phase 2

Atropine

Sponsor:

Rehan Ahmed

Code:

NCT07816224

Conditions

Epiphora

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atropine sulfate ophthalmic solution 0.005%

Vehicle arm

Study Details

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

Study ID

NCT07816224

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Atropine then vehicle

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

experimental: Vehicle then atropine

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

Interventions

Atropine sulfate ophthalmic solution 0.005%

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

Vehicle arm

Identical-appearing drops without atropine; one drop in the affected eye(s) once nightly at bedtime for 7 days. - Other name: Placebo

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rehan Ahmed, MD

studytearing@gmail.comstudytearing@gmail.com

Locations

Greater Houston Eye Consultants

Recruiting

Houston, Texas, United States, 77401

Contacts

Rehan Ahmed

7136616500studytearing@gmail.com

North Texas Eye Specialists

Recruiting

Mesquite, Texas, United States, 75150

Contacts

Rehan Ahmed, MD

972-807-5744studytearing@gmail.com

More Information

Sponsor

Rehan Ahmed

Last update posted

Oct 14, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Rehan Ahmed on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.