Placing a plug in the upper tear duct when the lower tear duct is already closed
Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.
NA · Universidad Autonoma de Nuevo Leon · NCT07571330
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Autonoma de Nuevo Leon (other) |
| Locations | 1 site (Monterrey, Nuevo León) |
| Trial ID | NCT07571330 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Monterrey, Nuevo León
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: DED, Aqueous-deficient Dry Eye Disease, Aqueous-deficient dry eye disease, Punctual plug, Superior punctual plug