NCT07372014

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
1mo left

Started Jan 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2026May 2026

Study Start

First participant enrolled

January 12, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2026

Expected
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 20, 2026

Last Update Submit

January 20, 2026

Conditions

EpiphoraPunctal Stenosis

Keywords

Lacrimal Apparatus DiseasesStenosisAnti-Inflammatory Agents, Non-Steroidal

Outcome Measures

Primary Outcomes (2)

  • Lacrimal punctal estenosis

    Lacrimal punctal stenosis measured by Optical Coherence Tomography and Kashkouli scale

    From enrollment to the end, each month of treatment until 8 weeks

  • Epiphora

    Epiphora measured by Munk scale

    From enrollment to the end, each month of treatment until 8 weeks

Study Arms (2)

Group 1: Nepafenac 0.1% ophthalmic suspension and lubricant

EXPERIMENTAL

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

Group 2: placebo and lubricant

PLACEBO COMPARATOR

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

Interventions

Nepafenac and lubricantDRUG

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

Group 1: Nepafenac 0.1% ophthalmic suspension and lubricant
PlaceboDRUG

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

Group 2: placebo and lubricant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Oftalmología F.A.P. Conde de Valenciana, I.A.P.

Mexico City, Mexico City, 06800, Mexico

Location

Related Publications (38)

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  • Nassief M, Lotfy NM. Topical cyclosporin A 0.05% eye drops for management of symptomatic acquired punctal stenosis: a prospective, controlled clinical study. Orbit. 2024 Apr;43(2):190-195. doi: 10.1080/01676830.2023.2232028. Epub 2023 Jul 18.

    PMID: 37463348RESULT

  • Vahdani K, Sian I, Giasin O, Makrygiannis G. Functional and anatomical outcomes of punctoplasty with Kelly punch. Eye (Lond). 2017 Nov;31(11):1628. doi: 10.1038/eye.2017.105. Epub 2017 Jun 2. No abstract available.

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  • Wong ES, Li EY, Yuen HK. Long-term outcomes of punch punctoplasty with Kelly punch and review of literature. Eye (Lond). 2017 Apr;31(4):560-565. doi: 10.1038/eye.2016.271. Epub 2016 Dec 2.

    PMID: 27911445RESULT

  • Dolin SL, Hecht SD. The punctum pucker procedure for stenosis of the lacrimal punctum. Arch Ophthalmol. 1986 Jul;104(7):1086-7. doi: 10.1001/archopht.1986.01050190144055.

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    RESULT

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    RESULT

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    RESULT

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    RESULT

  • Hussain RN, Kanani H, McMullan T. Use of mini-monoka stents for punctal/canalicular stenosis. Br J Ophthalmol. 2012 May;96(5):671-3. doi: 10.1136/bjophthalmol-2011-300670. Epub 2012 Jan 12.

    PMID: 22241928RESULT

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    PMID: 21386741RESULT

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    PMID: 18806663RESULT

  • Goldberg H, Priel A, Zloto O, Koval T, Varkel L, Ben Simon GJ. Kelly punch punctoplasty vs. simple punctal dilation, both with mini-monoka silicone stent intubation, for punctal stenosis related epiphora. Eye (Lond). 2021 Feb;35(2):532-535. doi: 10.1038/s41433-020-0891-3. Epub 2020 Apr 21.

    PMID: 32317792RESULT

  • Awny I, Mossa EAM, Bakheet TM, Mahmoud H, Mounir A. Changes of Lacrimal Puncta by Anterior Segment Optical Coherence Tomography after Topical Combined Antibiotic and Steroid Treatment in Cases of Inflammatory Punctual Stenosis. J Ophthalmol. 2022 Jan 24;2022:7988091. doi: 10.1155/2022/7988091. eCollection 2022.

    PMID: 35111339RESULT

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  • Kristan RW. Treatment of lacrimal punctal stenosis with a one-snip canaliculotomy and temporary punctal plugs. Arch Ophthalmol. 1988 Jul;106(7):878-9. doi: 10.1001/archopht.1988.01060140020006. No abstract available.

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    RESULT

  • Kakizaki H, Takahashi Y, Iwaki M, Nakano T, Asamoto K, Ikeda H, Goto E, Selva D, Leibovitch I. Punctal and canalicular anatomy: implications for canalicular occlusion in severe dry eye. Am J Ophthalmol. 2012 Feb;153(2):229-237.e1. doi: 10.1016/j.ajo.2011.07.010. Epub 2011 Oct 6.

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  • Awny I, Mossa EAM, Bakheet TM, Mahmoud H, Mounir A. Evaluation of Lacrimal Punctal Changes by Anterior Segment Optical Coherence Tomography after Punctal Dilation Versus Punctal Plug Insertion in Cases of Inflammatory Punctual Stenosis. J Ophthalmol. 2022 Oct 20;2022:7666323. doi: 10.1155/2022/7666323. eCollection 2022.

    PMID: 36311352RESULT

MeSH Terms

Conditions

Lacrimal Apparatus DiseasesConstriction, Pathologic

Interventions

nepafenacLubricants

Condition Hierarchy (Ancestors)

Eye DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is designed as a randomized clinical trial with a follow-up period of two months. Participants will be allocated into two groups through balanced block randomization. The first group will receive nepafenac ophthalmic suspension 0.1% once daily, in conjunction with sodium carboxymethylcellulose 0.5% three times daily, over an eight-week period. The second group will be administered a placebo alongside sodium carboxymethylcellulose 0.5% three times daily for the same duration. All assessments will be conducted by a single ophthalmologist. Prior to the initiation of treatment, at 4 and 8 weeks into the treatment, a clinical evaluation using a slit lamp will be performed to assess the visibility of the lacrimal punctum, utilizing the Kashkouli scale, and to evaluate epiphora according to the Munk scale. Additionally, baseline measurements of the external diameter and depth of the lacrimal punctum will be obtained using OCT-SA.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 28, 2026

Study Start

January 12, 2026

Primary Completion

March 2, 2026

Study Completion (Estimated)

May 29, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
January 2026 - December 2026

Locations

ME(1)