NCT07372014

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Epiphora
• Punctal Stenosis

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-03-02
• Completion: 2026-05-29
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Mexico