Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus
Key facts
- Who runs it
- University of Campinas, Brazil
- Where
- Brazil1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 3
- People taking part
- 19 people enrolled
- Started
- 1 Aug 2024
- Ended
- 20 Mar 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- NPH insulin 50 IU/mL eye drops
- 0.5% methylcellulose eye drops (placebo)
- Record updated
- 5 November 2026
- Why it stopped
- Enrollment closed before the planned 36 eyes were reached because of the limited number of eligible patients and the long recruitment period (July 2024 to December 2025); 20 eyes of 19 participants were enrolled.
Who can take part
- Age
- 14 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age 14 years or older
- Diagnosis of keratoconus with an indication for corneal crosslinking
Who cannot take part
- Diabetes mellitus
- Dry eye disease
- Allergy to insulin or methylcellulose
- Limbal stem cell deficiency
- Glaucoma
- Irregular epithelial debridement and/or debridement other than 8.0 mm during the crosslinking procedure
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The cornea plays a fundamental role in vision, being a complex tissue essential for ocular health. In ophthalmological practice, there are situations such as corneal crosslinking, where damage to the corneal epithelium occurs. Crosslinking is a surgical procedure aimed at strengthening collagen bonds in the corneal stroma to prevent the progression of keratoconus, through the application of topical riboflavin followed by ultraviolet (UV-A) radiation. To enhance the effectiveness of riboflavin and UV-A radiation, the corneal epithelium needs to be removed, which can cause postoperative pain and discomfort, as well as increase the risk of complications such as infections, scarring, corneal opacities, perforations, and recurrent epithelial erosions. Several growth factors play a role in epithelial healing, and the discovery of insulin in the tear film and the presence of insulin and Insulin-Like Growth Factor (IGF-1) receptors in the cornea has raised the hypothesis that insulin may modulate the cornea's wound healing response. Since then, topical insulin has been used for various ocular pathologies, including dry eye disease, persistent epithelial defects, and neurotrophic ulcers. Based on this knowledge, studies have been developed, and promising results regarding the use of insulin in corneal healing have been reported, providing a scientific foundation for the realization of this project.
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The objective of this study was to evaluate the effect of insulin eye drops at a concentration of 50 IU/ml on epithelial healing in non-diabetic patients undergoing epithelial debridement for corneal crosslinking. To this end, a randomized, double-masked clinical trial was conducted with two groups, one being the control group, in which researchers compared the epithelial healing rate in mm²/h between the insulin group and the placebo group, as the primary outcome. Patients diagnosed with keratoconus and with an indication for the crosslinking procedure were invited to participate.
The study was designed to assess and quantify the impact of topical insulin on epithelial defect closure in patients undergoing crosslinking, compared to placebo.
The 2 groups in the trial
- InsulinTreatment being tested
NPH insulin 50 IU/mL eye drops (Eye Pharma, São Paulo, SP, Brazil), one drop four times daily until complete corneal epithelialization, added to the standard postoperative regimen.
Treatment: NPH insulin 50 IU/mL eye drops
- PlaceboPlacebo, for comparison
0.5% methylcellulose eye drops (Eye Pharma, São Paulo, SP, Brazil), the vehicle of the insulin formulation, one drop four times daily until complete corneal epithelialization, added to the standard postoperative regimen.
Treatment: 0.5% methylcellulose eye drops (placebo)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus: A Randomized Clinical Trial
- Record updated
- 5 November 2026