NCT06601101 Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus
| NCT ID | NCT06601101 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Campinas, Brazil |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 36 participants in total. It began in 2024-08-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The objective of this study is 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 will be conducted with two groups, one being the control group, in which researchers will compare 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, will be invited to participate. As a result of the study, it is expected to assess and quantify the impact of topical insulin on epithelial defect closure in patients undergoing crosslinking, compared to placebo. Topical insulin may contribute to early epithelial defect closure, control of inflammation, and prevention of complications that could significantly impact visual quality.
Eligibility Criteria
Inclusion Criteria: * Patients with a diagnosis of keratoconus, indicated for corneal crosslinking Exclusion Criteria: * Diabetes Mellitus * Severe dry eye * Limbal Stem Cell Deficiency * Glaucoma * Insulin or methylcellulose allergy
Contact & Investigator
Monica Alves, PhD
STUDY CHAIR
State University of Campinas (Unicamp)
Frequently Asked Questions
Who can join the NCT06601101 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06601101 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 36 participants.
Is NCT06601101 currently recruiting?
Yes, NCT06601101 is actively recruiting participants. Contact the research team at vitorborgesguimaraes@gmail.com for enrollment information.
Where is the NCT06601101 trial being conducted?
This trial is being conducted at Campinas, Brazil.
Who is sponsoring the NCT06601101 clinical trial?
NCT06601101 is sponsored by University of Campinas, Brazil. The principal investigator is Monica Alves, PhD at State University of Campinas (Unicamp). The trial plans to enroll 36 participants.