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)

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Active, not recruiting; Phase 4

Conditions: Punctal Stenosis; Epiphora

Treatments: Drug: Placebo; Drug: Nepafenac and lubricant

Study type: Interventional

Funder types: Other

Identifiers

NCT07372014

CEI-2025/09/01

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Group 1: Nepafenac 0.1% ophthalmic suspension and lubricant

Experimental group

Description:

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

Treatment:

Drug: Nepafenac and lubricant

Group 2: placebo and lubricant

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo