Instituto de Oftalmología F.A.P. Conde de Valenciana, I.A.P.
Mexico City, 06800, Mexico
NCT Number: NCT07372014
Establish the efficacy of combined treatment with nepafenac and lubricant versus lubricant alone in improving epiphora and resolving punctal stenosis in Mexican adults.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 4
Mexico City, 06800, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: From enrollment to the end, each month of treatment until 8 weeks
Epiphora measured by Munk scale
Instituto de Oftalmología Fundación Conde de Valenciana
Other
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
Acronym: CAENLVLTELPMA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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