EpiphoraPhase 2NCT07676981
Atropine Eye Drops for Watery Eyes (Excessive Tearing)
A Phase 2 study testing Atropine ophthalmic solution in people with Epiphora, run by Rehan Ahmed at 2 sites in United States.
Trial summary
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. 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 ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jun 2026to 15 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Greater Houston Eye Consultants
Houston, Texas, 77098
North Texas Eye Specialists
Mesquite, Texas, 75150
About this study
Official title: 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:
Read more
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
- Conditions
- Epiphora
- Being tested
- Atropine ophthalmic solution
- 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 ophthalmic solutionDrug
The interventions are two low doses of atropine ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Atropine ophthalmic solution 0.005% | Experimental | Atropine ophthalmic solution 0.005% Receives: Drug: Atropine ophthalmic solution |
| Atropine ophthalmic solution 0.01% | Experimental | Atropine ophthalmic solution 0.01% Receives: Drug: Atropine ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Munk Score Change
Proportion of subjects achieving a clinically meaningful Munk responder response (reduction of ≥2 Munk grades from baseline to Visit 2)
Measured: Time Frame: From enrollment to the end of treatment at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start16 Jun 2026
- Primary completion6 Jul 2026
- Study completion15 Jul 2026
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
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
- NCT07676981
- Sponsor's protocol ID
- IND-180375-P2-001
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2026
- Last updated
- 10 Sep 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Dose-Ranging Study of Atropine Sulfate Ophthalmic Solution for the Treatment of Symptoms of Epiphora
- ClinicalTrials.gov ID
- NCT07676981
- Acronym / sponsor ID
- IND-180375-P2-001
- Conditions
- Epiphora
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rehan AhmedUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 30 Jun 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine ophthalmic solution 0.005% | Experimental | Drug: Atropine ophthalmic solutionAtropine ophthalmic solution 0.005% |
| Atropine ophthalmic solution 0.01% | Experimental | Drug: Atropine ophthalmic solutionAtropine ophthalmic solution 0.01% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 ophthalmic solutionThe interventions are two low doses of atropine ophthalmic solution | Drug | Atropine ophthalmic solution 0.005%, Atropine ophthalmic solution 0.01% |
Primary outcome
Munk Score Change
Time frame: Time Frame: From enrollment to the end of treatment at 1 week
Proportion of subjects achieving a clinically meaningful Munk responder response (reduction of ≥2 Munk grades from baseline to Visit 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 ophthalmic solution 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?
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: finished, as of the sponsor's last update on 10 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Munk Score Change (time frame: Time Frame: From enrollment to the end of treatment at 1 week). 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 10 Sep 2026.