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Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.

4. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

36

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Rekruttering
        • Ophthalmology Department
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
1. Effectiveness
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in lower tear meniscus heigh
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidad Autonoma de Nuevo Leon

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. februar 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

12. februar 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • OF25-00001

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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