A Phase 4 interventional study of Nepafenac and lubricant and Placebo in Epiphora and Punctal Stenosis, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Active, not recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Phase 4, Interventional, and Treatment
Establish the efficacy of combined treatment with nepafenac and lubricant versus lubricant alone in improving epiphora and resolving punctal stenosis in Mexican adults.
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.
36 studies on the registry are indexed under Lacrimal Apparatus Diseases; 2 are open to participants now.
This study's planned enrollment of 68 is above the median of 29 across 26 interventional studies indexed under Lacrimal Apparatus Diseases.
Browse Lacrimal Apparatus Diseases studies →Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
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
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
Lacrimal punctal estenosis
Lacrimal punctal stenosis measured by Optical Coherence Tomography and Kashkouli scale
Time frame: From enrollment to the end, each month of treatment until 8 weeks
Epiphora
Epiphora measured by Munk scale
Time frame: From enrollment to the end, each month of treatment until 8 weeks
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Instituto de Oftalmología Fundación Conde de Valenciana