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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac and lubricant | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de OftalmologÃa F.A.P. Conde de Valenciana, I.A.P. | Mexico City | Mexico City | 06800 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36470407 | Result | 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. | |
| 9599360 | Result | 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. |
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January 2026 - December 2026
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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.
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|
| Placebo | Drug | 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 |
|
| 11820911 | Result | 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. |
| 24345529 | Result | 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. |
| 29375191 | Result | Nepafenac. Aust Prescr. 2017 Dec;40(6):246-247. doi: 10.18773/austprescr.2017.071. Epub 2017 Oct 3. No abstract available. |
| 32546955 | Result | 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. |
| 11320025 | Result | 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. |
| 24935281 | Result | 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. |
| 27536206 | Result | 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. |
| 30325678 | Result | 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. |
| 8306663 | Result | 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. |
| 37463348 | Result | 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. |
| 28574492 | Result | 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. |
| 27911445 | Result | 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. |
| 3729781 | Result | 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. |
| 6059676 | Result | Hughes WL, Maris CS. A clip procedure for stenosis and eversion of the lacrimal punctum. Trans Am Acad Ophthalmol Otolaryngol. 1967 Jul-Aug;71(4):653-5. No abstract available. |
| 14452301 | Result | JONES LT. The cure of epiphora due to canalicular disorders, trauma and surgical failures on the lacrimal passages. Trans Am Acad Ophthalmol Otolaryngol. 1962 Jul-Aug;66:506-24. No abstract available. |
| Result | Arlit F. Surgery of the lacrimal system. En: Graefe A, Saemisch T, editores. Handbook of the entire ophthalmology Leipzig, East Germany Publisher: Von Wilhelm Englemann. 1874 |
| Result | Bowman W. Treatment method applicable to epiphora dependent on the outside reversal or obliteration of the lacrimal puncti. Ann Oculist. 1853;28:52-5 |
| 22241928 | 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. |
| 21386741 | Result | Mathew RG, Olver JM. Mini-monoka made easy: a simple technique for mini-monoka insertion in acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2011 Jul-Aug;27(4):293-4. doi: 10.1097/IOP.0b013e31820ccfaf. |
| 18806663 | Result | Konuk O, Urgancioglu B, Unal M. Long-term success rate of perforated punctal plugs in the management of acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2008 Sep-Oct;24(5):399-402. doi: 10.1097/IOP.0b013e318185a9ca. |
| 32317792 | Result | 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. |
| 35111339 | Result | 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. |
| 25215411 | Result | Wawrzynski JR, Smith J, Sharma A, Saleh GM. Optical coherence tomography imaging of the proximal lacrimal system. Orbit. 2014 Dec;33(6):428-32. doi: 10.3109/01676830.2014.949793. Epub 2014 Sep 12. |
| 30270476 | Result | Jiao H, Hill LJ, Downie LE, Chinnery HR. Anterior segment optical coherence tomography: its application in clinical practice and experimental models of disease. Clin Exp Optom. 2019 May;102(3):208-217. doi: 10.1111/cxo.12835. Epub 2018 Oct 1. |
| 2243969 | Result | Munk PL, Lin DT, Morris DC. Epiphora: treatment by means of dacryocystoplasty with balloon dilation of the nasolacrimal drainage apparatus. Radiology. 1990 Dec;177(3):687-90. doi: 10.1148/radiology.177.3.2243969. |
| 18609466 | Result | Kashkouli MB, Nilforushan N, Nojomi N, Rezaee R. External lacrimal punctum grading: reliability and interobserver variation. Eur J Ophthalmol. 2008 Jul-Aug;18(4):507-11. doi: 10.1177/112067210801800401. |
| 8217962 | Result | Offutt WN 4th, Cowen DE. Stenotic puncta: microsurgical punctoplasty. Ophthalmic Plast Reconstr Surg. 1993;9(3):201-5. doi: 10.1097/00002341-199309000-00006. |
| 14644218 | Result | Kashkouli MB, Beigi B, Murthy R, Astbury N. Acquired external punctal stenosis: etiology and associated findings. Am J Ophthalmol. 2003 Dec;136(6):1079-84. doi: 10.1016/s0002-9394(03)00664-0. |
| 20142967 | Result | Bukhari A. Prevalence of punctal stenosis among ophthalmology patients. Middle East Afr J Ophthalmol. 2009 Apr;16(2):85-7. doi: 10.4103/0974-9233.53867. |
| 3390040 | Result | 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. |
| 11320034 | Result | Esmaeli B, Valero V, Ahmadi MA, Booser D. Canalicular stenosis secondary to docetaxel (taxotere): a newly recognized side effect. Ophthalmology. 2001 May;108(5):994-5. doi: 10.1016/s0161-6420(00)00640-0. |
| 37641620 | Result | Nassief M, Alduwailah OKM, Lotfy NM. Acquired symptomatic external punctal stenosis: a tertiary referral center study. Med Hypothesis Discov Innov Ophthalmol. 2021 May 31;10(1):18-23. doi: 10.51329/mehdiophthal1417. eCollection 2021 Spring. |
| Result | Olver J. Colour Atlas of Lacrimal Surgery. Inglaterra: Butterworth-Heinemann; 2002 |
| 21982102 | 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. |
| 22848141 | Result | Soiberman U, Kakizaki H, Selva D, Leibovitch I. Punctal stenosis: definition, diagnosis, and treatment. Clin Ophthalmol. 2012;6:1011-8. doi: 10.2147/OPTH.S31904. Epub 2012 Jul 3. |
| 36311352 | Result | 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. |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| D054327 | Lubricants |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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