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Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.

4 maggio 2026 aggiornato da: Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon

Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.

This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This prospective, consecutive, interventional, longitudinal, case series study includes patients with aqueous-deficient dry eye disease who have inferior punctal occlusion. The study aims to evaluate the effect of superior lacrimal punctal occlusion with a plug dry eye symptoms and signs. Assessments will be performed at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months following superior punctal occlusion

Tipo di studio

Interventistico

Iscrizione (Stimato)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Messico
    • Nuevo León
      • Monterrey, Nuevo León, Messico, 64460
        • Reclutamento
        • Ophthalmology Department
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who
1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.
Procedura: Punctal plug occlusion
Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
1. Effectiveness
Lasso di tempo: Baseline, 2 weeks, 4 weeks, 3 months and 6 months
To evaluate signs and symptoms of dry eye, after superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum at baseline, 2 weeks, 4 weeks, 3 months and 6 months
Baseline, 2 weeks, 4 weeks, 3 months and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in lower tear meniscus heigh
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.
Change in lower tear meniscus height measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Change in lower tear meniscus area
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.
Change in lower tear meniscus area measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Change from baseline in dry eye severity as assessed by the Ocular Surface Disease Index (OSDI)
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.

The OSDI is a validated 12-item questionnaire evaluating dry eye symptoms and their impact on vision-related functioning across three domains: ocular symptoms, visual function, and environmental triggers. Each item is scored on a 5-point scale (0 = none of the time to 4 = all of the time). The total OSDI score is calculated as:

OSDI= number of questions answered (sum of scores)×25

Scores range from 0 to 100, with higher scores indicating greater disability. Severity categories are: normal (0-12), mild (13-22), moderate (23-32), and severe (33-100).
Baseline to 3 months after upper punctal plug placement.
Change from baseline in dry eye symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) scale.
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.

The SANDE is a validated, patient-reported outcome measuring dry eye symptom burden using two 100-mm visual analog scales assessing frequency and severity of symptoms (0 = none, 100 = maximal). The composite SANDE score is calculated as the square root of the product of frequency and severity scores:

Higher scores indicate worse symptoms.
Baseline to 3 months after upper punctal plug placement.
Change in tear film break-up time (TFBUT).
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.
Change in tear film break-up time measured with fluorescein after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Change in non-invasive tear break-up time (NIBUT).
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.
Change in non-invasive tear break-up time measured using Keratograph after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Change from baseline in ocular surface damage as assessed by the SICCA Ocular Surface Staining Score (OSS).
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.
The SICCA OSS is a standardized clinical grading system developed by the Sjögren's International Collaborative Clinical Alliance to quantify ocular surface epithelial damage using vital dyes. The score combines fluorescein corneal staining and lissamine green conjunctival staining in each eye.
Baseline to 3 months after upper punctal plug placement.
Change from baseline in corneal epithelial damage as assessed by the National Eye Institute Corneal Fluorescein Staining (NEI) score
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.

The NEI corneal fluorescein staining score is a standardized slit-lamp-based grading system used to quantify corneal epithelial damage after fluorescein instillation. The cornea is divided into five regions (central, superior, inferior, nasal, and temporal). Each region is graded on a 0 to 3 scale based on staining density and extent:

0 = no staining

  1. = sparse punctate staining
  2. = moderate/dense punctate staining
  3. = severe staining or coalescent areas

The total NEI score is the sum of all regions, ranging from 0 to 15, with higher scores indicating greater corneal epithelial damage.
Baseline to 3 months after upper punctal plug placement.
Change in Schirmer I test results.
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.
Change in tear production measured using the Schirmer I test with and without anesthesia after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Change in corneal sensitivity.
Lasso di tempo: Baseline to 3 months after upper punctal plug placement.
Change in corneal sensitivity measured by corneal esthesiometry after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Incidence of epiphora after upper punctal plug placement.
Lasso di tempo: Up to 3 months after upper punctal plug placement.
Incidence of epiphora reported after upper punctal plug placement during the follow-up period.
Up to 3 months after upper punctal plug placement.
Upper punctal plug retention rate.
Lasso di tempo: Up to 3 months after upper punctal plug placement.
Proportion of upper punctal plugs remaining in place during the follow-up period after placement.
Up to 3 months after upper punctal plug placement.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Autonoma de Nuevo Leon

Investigatori

  • Investigatore principale: Karim Mohamed-Noriega, Dr. med., Universidad Autonoma de Nuevo Leon

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 14. Qiu, W., Liu, Z., Ao, M., Li, X., & Wang, W. (2013). Punctal plugs versus artificial tears for treating primary Sjögren's syndrome with keratoconjunctivitis SICCA: A comparative observation of their effects on visual function. Rheumatology International, 33(10), 2543-2548. https://doi.org/10.1007/s00296-013-2769-1
  • 13. Perez, V. L., Chen, W., Craig, J. P., Dogru, M., Jones, L., Stapleton, F., Wolffsohn, J. S., & Sullivan, D. A. (2025). TFOS DEWS III: Executive Summary. American Journal of Ophthalmology. https://doi.org/10.1016/j.ajo.2025.09.035
  • 12. Marcet, M. M., Shtein, R. M., Bradley, E. A., Deng, S. X., Meyer, D. R., Bilyk, J. R., Yen, M. T., Lee, W. B., Mawn, L. A., & Lum, F. (2015a). Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome A Report by the American Academy of Ophthalmology. Ophthalmology, 122(8), 1681-1687. https://doi.org/10.1016/j.ophtha.2015.04.034
  • 11. Lanza NL, Valenzuela F, Perez VL, Galor A. The Matrix Metalloproteinase 9 Point-of-Care Test in Dry Eye. Ocul Surf [Internet]. 2016 Apr 1;14(2):189-95. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1542012416000082
  • 10. Kaido, M., Ishida, R., Dogru, M., & Tsubota, K. (2013). Comparison of retention rates and complications of 2 different types of silicon lacrimal punctal plugs in the treatment of dry eye disease. American Journal of Ophthalmology, 155(4). https://doi.org/10.1016/j.ajo.2012.10.024
  • 9. Hallali, G., Guindolet, D., Gabison, E. E., Cochereau, I., & Doan, S. (2024a). Immediate and Delayed Effects of Punctal Plug Insertion on Tear Meniscus Height in Severe Aqueous-Deficient Dry Eye. www.corneajrnl.com
  • 8. Craig, J. P., Nichols, K. K., Akpek, E. K., Caffery, B., Dua, H. S., Joo, C. K., Liu, Z., Nelson, J. D., Nichols, J. J., Tsubota, K., & Stapleton, F. (2017a). TFOS DEWS II Definition and Classification Report. In Ocular Surface (Vol. 15, Issue 3, pp. 276-283). Elsevier Inc. https://doi.org/10.1016/j.jtos.2017.05.008
  • 7. Chen, F., Wang, J., Chen, W., Shen, M., Xu, S., & Lu, F. (2010). Upper punctal occlusion versus lower punctal occlusion in dry eye. Investigative Ophthalmology and Visual Science, 51(11), 5571-5577. https://doi.org/10.1167/iovs.09-5097
  • 6. Chen, F., Shen, M., Chen, W., Wang, J., Li, M., Yuan, Y., & Lu, F. (2010). Tear meniscus volume in dry eye after punctal occlusion. Investigative Ophthalmology and Visual Science, 51(4), 1965-1969. https://doi.org/10.1167/iovs.09-4349
  • 5. Burgess, P. I., Koay, P., & Clark, P. (n.d.). SmartPlug Versus Silicone Punctal Plug Therapy for Dry Eye A Prospective Randomized Trial.
  • 4. Boldin, I., Klein, A., Haller-Schober, E. M., & Horwath-Winter, J. (2008). Long-term Follow-up of Punctal and Proximal Canalicular Stenoses After Silicone Punctal Plug Treatment in Dry Eye Patients. American Journal of Ophthalmology, 146(6). https://doi.org/10.1016/j.ajo.2008.06.028
  • 3. Balaram, M., Schaumberg, D. A., & Dana, M. R. (2001). Efficacy and Tolerability Outcomes After Punctal Occlusion With Silicone Plugs in Dry Eye Syndrome.
  • 2. Ali, M. J., & Singh, S. (2021). Optical coherence tomography and the proximal lacrimal drainage system: a major review. In Graefe's Archive for Clinical and Experimental Ophthalmology (Vol. 259, Issue 11, pp. 3197-3208). Springer Science and Business Media Deutschland GmbH. https://doi.org/10.1007/s00417-021-05175-3
  • 1. Ahn, H., Ji, Y. W., Jun, I., Kim, T. I., Lee, H. K., & Seo, K. Y. (2022). Comparison of Treatment Modalities for Dry Eye in Primary Sjogren's Syndrome. Journal of Clinical Medicine, 11(2). https://doi.org/10.3390/jcm11020463

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 febbraio 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

12 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 febbraio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • OF25-00001

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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