Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.
Mexico36 participantsStarted 2026-02-12
Plain-language summary
This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people who already have a lower punctal plug in place — does my current treatment history with punctal occlusion make me a realistic candidate to discuss with you?
2Since this trial is listed as Phase NA, what does that mean for how much is already known about the safety and effectiveness of adding an upper punctal plug on top of a lower one, and how does that affect the risk-benefit conversation for me?
3The trial is measuring 'effectiveness' as its primary outcome — can you explain what specific improvements they're looking for, like symptom relief or tear film measurements, and whether those outcomes matter most for my type of aqueous-deficient dry eye?
4If I were to discuss joining this trial, how would adding an upper punctal plug change my day-to-day experience compared to just continuing with my current lower punctal plug, and are there any discomfort or complications I should be aware of?
5Before considering this trial, is there a standard next step in treatment for aqueous-deficient dry eye that I should try first, or does my situation suggest it's worth asking about this upper punctal plug approach sooner?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.