AzTrials
AzTrials

EpiphoraPhase 4CAENLVLTELPMANCT07372014

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 Phase 4 study testing Nepafenac and lubricant in people with Epiphora and Punctal Stenosis, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Epiphora, Punctal Stenosis
What is being tested?
Nepafenac and lubricant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteMexico
Study dates
12 Jan 2026to 29 May 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Mexico1 site
  • Instituto de Oftalmología F.A.P. Conde de Valenciana, I.A.P.

    Mexico City, Mexico City, 06800

Other trials in Mexico

About this study

Official title: 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

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

Read the 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.

Being tested
Nepafenac and lubricant, Placebo
Keywords
Lacrimal Apparatus Diseases, Stenosis, Anti-Inflammatory Agents, Non-Steroidal
Medical subject headings
Lacrimal Apparatus Diseases, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT07372014
Study groupRoleWhat they receive
Group 1: Nepafenac 0.1% ophthalmic suspension and lubricantExperimentalThe 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
Receives: Drug: Nepafenac and lubricant
Group 2: placebo and lubricantPlacebo comparatorThe 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lacrimal punctal estenosis

    Lacrimal punctal stenosis measured by Optical Coherence Tomography and Kashkouli scale

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

  2. Epiphora

    Epiphora measured by Munk scale

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start12 Jan 2026
  3. Primary completion2 Mar 2026 (estimated)
  4. Study completion29 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07372014
Sponsor's protocol ID
CEI-2025/09/01
Acronym
CAENLVLTELPMA
Status last verified
Jan 2026
First submitted
20 Jan 2026
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Ceylanoglu KS, Sen EM. The effect of topical steroids and non-steroidal anti inflammatory drugs on epiphora of unknown cause: Optical coherence tomography study. Photodiagnosis Photodyn Ther. 2023 Mar;41:103234. doi: 10.1016/j.pdpdt.2022.103234. Epub 2022 Dec 5.

    PubMed 36470407
  • Assouline M, Renard G, Arne JL, David T, Lasmolles C, Malecaze F, Pouliquen YJ. A prospective randomized trial of topical soluble 0.1% indomethacin versus 0.1% diclofenac versus placebo for the control of pain following excimer laser photorefractive keratectomy. Ophthalmic Surg Lasers. 1998 May;29(5):365-74.

    PubMed 9599360
  • McGhee CN, Dean S, Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Saf. 2002;25(1):33-55. doi: 10.2165/00002018-200225010-00004.

    PubMed 11820911
  • Modi SS, Lehmann RP, Walters TR, Fong R, Christie WC, Roel L, Nethery D, Sager D, Tsorbatzoglou A, Philipson B, Traverso CE, Reiser H. Once-daily nepafenac ophthalmic suspension 0.3% to prevent and treat ocular inflammation and pain after cataract surgery: phase 3 study. J Cataract Refract Surg. 2014 Feb;40(2):203-11. doi: 10.1016/j.jcrs.2013.07.042. Epub 2013 Dec 15.

    PubMed 24345529
  • Nepafenac. Aust Prescr. 2017 Dec;40(6):246-247. doi: 10.18773/austprescr.2017.071. Epub 2017 Oct 3. No abstract available.

    PubMed 29375191
  • Elshorbagy MS, Shalaby OE, Eldesouky MA, Awara AM. Anterior Segment Optical Coherence Tomography (AS-OCT) Guided Reversal of Edematous Punctal Occlusion. Clin Ophthalmol. 2020 May 27;14:1467-1472. doi: 10.2147/OPTH.S255979. eCollection 2020.

    PubMed 32546955
  • Guidera AC, Luchs JI, Udell IJ. Keratitis, ulceration, and perforation associated with topical nonsteroidal anti-inflammatory drugs. Ophthalmology. 2001 May;108(5):936-44. doi: 10.1016/s0161-6420(00)00538-8.

    PubMed 11320025
  • Kessel L, Tendal B, Jorgensen KJ, Erngaard D, Flesner P, Andresen JL, Hjortdal J. Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review. Ophthalmology. 2014 Oct;121(10):1915-24. doi: 10.1016/j.ophtha.2014.04.035. Epub 2014 Jun 14.

    PubMed 24935281
  • Ambroziak AM, Szaflik J, Szaflik JP, Ambroziak M, Witkiewicz J, Skopinski P. Immunomodulation on the ocular surface: a review. Cent Eur J Immunol. 2016;41(2):195-208. doi: 10.5114/ceji.2016.60995. Epub 2016 Jul 15.

    PubMed 27536206
  • Moon I, Kang HG, Yeo A, Noh H, Kim HC, Song JS, Ji YW, Lee HK. Comparison of Ocular Surface Mucin Expression After Topical Ophthalmic Drug Administration in Dry Eye-Induced Mouse Model. J Ocul Pharmacol Ther. 2018 Nov;34(9):612-620. doi: 10.1089/jop.2018.0005. Epub 2018 Oct 16.

    PubMed 30325678
  • Holland EJ, Olsen TW, Ketcham JM, Florine C, Krachmer JH, Purcell JJ, Lam S, Tessler HH, Sugar J. Topical cyclosporin A in the treatment of anterior segment inflammatory disease. Cornea. 1993 Sep;12(5):413-9. doi: 10.1097/00003226-199309000-00008.

    PubMed 8306663
  • 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.

    PubMed 37463348
  • 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.

    PubMed 28574492
  • 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.

    PubMed 27911445
  • 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.

    PubMed 3729781

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nepafenac and lubricant in people with Epiphora and Punctal Stenosis, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lacrimal punctal estenosis (time frame: From enrollment to the end, each month of treatment until 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07372014, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in