EpiphoraPhase 2NCT07816224
Low-Dose Atropine Eye Drops for Excessive Tearing (Epiphora)
A Phase 2 study testing Atropine sulfate ophthalmic solution 0.005% in people with Epiphora, run by Rehan Ahmed at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiphora
- What is being tested?
- Atropine sulfate ophthalmic solution 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Greater Houston Eye Consultants
Houston, Texas, 77401
Rehan Ahmed, 7136616500, studytearing@gmail.com
- Recruiting
North Texas Eye Specialists
Mesquite, Texas, 75150
Rehan Ahmed, MD, 972-807-5744, studytearing@gmail.com
About this study
Official 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
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
- Being tested
- Atropine sulfate ophthalmic solution 0.005%, Vehicle arm
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine sulfate ophthalmic solution 0.005%Drug
One drop in the affected eye(s) once nightly at bedtime for 7 days.
Vehicle armDrug
Identical-appearing drops without atropine; one drop in the affected eye(s) once nightly at bedtime for 7 days. - Other name: Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Atropine sulfate ophthalmic solution 0.005%; Drug: Vehicle arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpiphoraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehan Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehan Ahmed, Greater Houston Eye Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816224
- Sponsor's protocol ID
- IND-180375-P2B-001
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07816224
- Acronym / sponsor ID
- IND-180375-P2B-001
- Conditions
- Epiphora
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Rehan AhmedUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine then vehicle | Experimental | Drug: Atropine sulfate ophthalmic solution 0.005%, Drug: Vehicle armAtropine then vehicle - Description: Atropine 0.005% nightly for 7 days, approximately 14-day washout, then vehicle nightly for 7 days. |
| Vehicle then atropine | Experimental | Drug: Atropine sulfate ophthalmic solution 0.005%, Drug: Vehicle armVehicle then atropine - Description: Vehicle nightly for 7 days, approximately 14-day washout, then atropine 0.005% nightly for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine sulfate ophthalmic solution 0.005%One drop in the affected eye(s) once nightly at bedtime for 7 days. | Drug | Atropine then vehicle, Vehicle then atropine |
| Vehicle armIdentical-appearing drops without atropine; one drop in the affected eye(s) once nightly at bedtime for 7 days. - Other name: Placebo | Drug | Atropine then vehicle, Vehicle then atropine |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atropine sulfate ophthalmic solution 0.005% in people with Epiphora, run by Rehan Ahmed at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rehan Ahmed, MD (studytearing@gmail.com, studytearing@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.