Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.

NCT07571330 | Recruiting

• 1 other identifier: OF25-00001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

DED; Aqueous-deficient Dry Eye Disease

Keywords

Aqueous-deficient dry eye disease; DED; Punctual plug; Superior punctual plug

Outcome Measures

Primary Outcomes (1)

• 1. Effectiveness

  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

Secondary Outcomes (12)

• Change in lower tear meniscus heigh

  Baseline to 3 months after upper punctal plug placement.

• Change in lower tear meniscus area

  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)

  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.

  Baseline to 3 months after upper punctal plug placement.

• Change in tear film break-up time (TFBUT).

  Baseline to 3 months after upper punctal plug placement.

Study Arms (1)

1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who

EXPERIMENTAL

1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.

Procedure: Punctal plug occlusion

Interventions

Punctal plug occlusion PROCEDURE

Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.

1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Active ocular surface infection.
• Patients who are unwilling to participate or to provide written informed consent.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Ophthalmology Department

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (14)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 5. Burgess, P. I., Koay, P., & Clark, P. (n.d.). SmartPlug Versus Silicone Punctal Plug Therapy for Dry Eye A Prospective Randomized Trial.

  BACKGROUND

• 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

  BACKGROUND

• 3. Balaram, M., Schaumberg, D. A., & Dana, M. R. (2001). Efficacy and Tolerability Outcomes After Punctal Occlusion With Silicone Plugs in Dry Eye Syndrome.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Study Officials

• Karim Mohamed-Noriega, Dr. med.

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim Mohamed-Noriega, Dr. med.

CONTACT

+52 8113404960; karim.mohamednr@uanl.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, consecutive, interventional case series study of patients with aqueous-deficient dry eye disease.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: May 6, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-02

Locations

ME (1)