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Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.

4 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

36

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • México
    • Nuevo León
      • Monterrey, Nuevo León, México, 64460
        • Reclutamiento
        • Ophthalmology Department
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
1. Effectiveness
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in lower tear meniscus heigh
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Universidad Autonoma de Nuevo Leon

Investigadores

  • Investigador principal: Karim Mohamed-Noriega, Dr. med., Universidad Autonoma de Nuevo Leon

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • 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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de febrero de 2026

Finalización primaria (Estimado)

1 de octubre de 2026

Finalización del estudio (Estimado)

1 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2026

Última verificación

1 de febrero de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • OF25-00001

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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