A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis (CAENLVLTELPMA)

January 20, 2026 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis in Mexican Adults

Establish the efficacy of combined treatment with nepafenac and lubricant versus lubricant alone in improving epiphora and resolving punctal stenosis in Mexican adults.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A two-month follow-up will be conducted. The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks. Initial evaluations will be conducted, followed by assessments at four and eight weeks to determine, through ophthalmological examination, the visibility of the lacrimal punctum using the Kashkouli scale, the assessment of epiphora according to the Munk scale, and the measurement of the external diameter and depth of the lacrimal punctum using OCT-SA.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06800
        • Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of epiphora secondary to lacrimal punctum stenosis of allergic or idiopathic origin. Age ≥ 18 years

Exclusion Criteria:

  • Previous eye surgery, including eyelid or lacrimal duct surgery. Allergy to nepafenac. Previous application of botulinum toxin to the eyelids, medical treatment received at least 3 months prior to the study, treatment discontinuation, failure to attend scheduled follow-up appointments and severe adverse reactions to treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Nepafenac 0.1% ophthalmic suspension and lubricant
The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks
Drug: Nepafenac and lubricant
A two-month follow-up will be conducted. The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks
Placebo Comparator: Group 2: placebo and lubricant
The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks
Drug: Placebo
A two-month follow-up will be conducted. The study participants will be randomly assigned to two groups: the first group will receive treatment with nepafenac 0.1% ophthalmic suspension once daily and sodium carboxymethylcellulose 0.5% (lubricant) three times daily for eight weeks; the second group will receive treatment with placebo and lubricant only, administered three times daily for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lacrimal punctal estenosis
Time Frame: From enrollment to the end, each month of treatment until 8 weeks
Lacrimal punctal stenosis measured by Optical Coherence Tomography and Kashkouli scale
From enrollment to the end, each month of treatment until 8 weeks
Epiphora
Time Frame: From enrollment to the end, each month of treatment until 8 weeks
Epiphora measured by Munk scale
From enrollment to the end, each month of treatment until 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

May 29, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-2025/09/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

January 2026 - December 2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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