Efficacy of Topical Insuline Drops in Corneal Epithelial Healing Post PRK in Non Diabetic Patients: an Randomized-controlled Trial
Sponsor study identifier
interventional
100
1 country
1
Study Start
April 25, 2025
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Primary Completion
June 2025
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Study Completion
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A prospective randomized double-blind controlled trial will be conducted. The informed consent of each patient will be obtained prior to the procedure. All patients will undergo a classic PRK procedure Patients will be instructed to use eye drops blindly in both eyes at a frequency of six times daily:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 25, 2025
Actual (reported)April 25, 2025
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May 4, 2025
Actual (reported)June 2025
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July 2025
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Corneal epithelial healing
Corneal epithelial defect will be measured ar Day 2 and Day 4 using slit images.
From enrollement to day 4 post PRK
Pain/discomfort
day 4 post PRK
Eyes receiving eye drops containing human insulin 1U/mL
Eyes only receiving artificial tears
Use of topical insulin eye drops following a standard excimer laser photo-refractive keratecotmy in myopic/astigmatic patients, in order to examine its efficacy in promoting corneal epithelial healing and patient comfort
The other arm receiving only artificial tears
Hotel Dieu de France hospital
Beirut, 166830, Lebanon
Fernandez, MD Alvarado, et al. "3PC-066 Compounding an eye drop formulation of topical insulin for corneal defects refractory to previous treatment: experience in real clinical practice
Serrano-Gimenez R, Contreras-Macias E, Garcia-Bernal A, Fobelo-Lozano MJ. Insulin eye drops for treating corneal ulcer in a non-diabetic patient: regarding a case. Farm Hosp. 2020 Oct 6;44(6):297-299. doi: 10.7399/fh.11521.
Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.
First Submitted
April 25, 2025
First Posted
May 4, 2025
Study Start
April 25, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2025
Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers
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Gómez, M. M., Albaladejo, P. M., Sanz, I. R., Crespo, C. B., Durán, J. P., Alemany, A. L., ... & Martí, M. C. (2022). 3PC-020 Chemical stability and physical compatibility of insulin eye drops used in clinical practice.
Castro Mora MP, Palacio Varona J, Perez Riano B, Laverde Cubides C, Rey-Rodriguez DV. Effectiveness of topical insulin for the treatment of surface corneal pathologies. Arch Soc Esp Oftalmol (Engl Ed). 2023 Apr;98(4):220-232. doi: 10.1016/j.oftale.2023.03.007. Epub 2023 Mar 5.
Stuard WL, Titone R, Robertson DM. The IGF/Insulin-IGFBP Axis in Corneal Development, Wound Healing, and Disease. Front Endocrinol (Lausanne). 2020 Mar 3;11:24. doi: 10.3389/fendo.2020.00024. eCollection 2020.
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Study Completion
July 2025
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Last Updated
May 4, 2025
Record last verified: 2025-04
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