Placing a plug in the upper tear duct when the lower tear duct is already closed
Official title: Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.
Run by Universidad Autonoma de Nuevo Leon · NCT07571330 · Data updated 2026-11-12
This will try placing a plug in the upper tear duct to see if it improves symptoms in adults with aqueous-deficient dry eye who already have their lower puncta closed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Universidad Autonoma de Nuevo Leon Academic / other |
| Locations | 1 site (Monterrey, Nuevo León) |
| Status | Recruiting |
| Started | February 12, 2026 |
| Main results expected | October 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07571330 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with aqueous-deficient dry eye, a clinically sealed inferior punctum, a functional superior punctum, OSDI >13, and at least one objective sign (e.g., low TBUT or reduced Schirmer) are ideal candidates.
✕Probably not a fit
Patients with active ocular surface infection, no functional superior punctum, or dry eye not primarily due to aqueous deficiency may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, consecutive, interventional, longitudinal case series enrolling adults with aqueous-deficient dry eye who have prior inferior punctal occlusion. Eligible participants with a functional superior punctum will receive a superior punctal plug and be followed for signs and symptoms. Outcome measures include symptom scores (OSDI) and objective tear-film and ocular-surface tests (TBUT, Schirmer, fluorescein and conjunctival staining) measured at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months. The design focuses on within-patient changes after adding superior punctal occlusion to existing lower occlusion.
Why it matters
Potential benefit: If successful, adding an upper punctal plug could increase tear retention and reduce dry eye symptoms in patients who already have lower punctal occlusion.
How similar studies have gone: Punctal occlusion is an established treatment for aqueous-deficient dry eye, but deliberately adding an upper plug when the lower punctum is already closed has been less commonly reported and lacks large-scale trial evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes * One or both eyes may be included * Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination * Functional superior lacrimal punctum * Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.) * Age \>18 years * OSDI score \>13 and one of the following signs: Tear film markers (Fluorescein tear break up-time \<5, First non-invasive tear breakup time \<10, Schirmer test without anesthesia \<10 mm, Schirmer test with anesthesia \<10 mm), Ocular surface markers (corneal staining \>5 spots or conjunctival staining \>9 spots). Exclusion Criteria: * Active ocular surface infection. * Patients who are unwilling to participate or to provide written informed consent.
Where it's running
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Ophthalmology Department
Monterrey, Nuevo León, Mexico Recruiting
Study contacts
- Principal investigator: Karim Mohamed-Noriega, Dr. med. — Universidad Autonoma de Nuevo Leon
- Study coordinator: Karim Mohamed-Noriega, Dr. med.
- Email: karim.mohamednr@uanl.edu.mx
- Phone: +52 8113404960
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.