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Multicenter, controlled, randomized, observer-blinded clinical trial to evaluate the efficacy and safety of insulin eye drops (1 IU/ml) in the treatment of persistent corneal epithelial defect.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518818-53-00
Acronym
INSULINADEP-22
Enrollment
234
Registered
2024-11-06
Start date
2023-09-26
Completion date
Unknown
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent corneal epithelial defect.

Brief summary

Closure or non-closure of the persistent epithelial defect, expressed as percentage of patients with complete re-epithelialisation., Closure rate (area of initial defect / days to epithelialisation, in mm2/day)., Time to complete closure (in days) (closure in first two weeks of treatment: complete success; closure in first month of treatment: partial success).

Detailed description

Percentage of patients with insufficient response., Percentage of patients with treatment failure., Description of other variables and relationship with response: age, sex, comorbidities, aetiology of the epithelial defect, time since diagnosis, previous treatment, previous surgeries, visual acuity., Closure or not of the PED and rate of closure in those patients who receive both treatments due to insufficient effect of one of them in isolation.

Interventions

Sponsors

Hospital Clinico San Carlos
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Closure or non-closure of the persistent epithelial defect, expressed as percentage of patients with complete re-epithelialisation., Closure rate (area of initial defect / days to epithelialisation, in mm2/day)., Time to complete closure (in days) (closure in first two weeks of treatment: complete success; closure in first month of treatment: partial success).

Secondary

MeasureTime frame
Percentage of patients with insufficient response., Percentage of patients with treatment failure., Description of other variables and relationship with response: age, sex, comorbidities, aetiology of the epithelial defect, time since diagnosis, previous treatment, previous surgeries, visual acuity., Closure or not of the PED and rate of closure in those patients who receive both treatments due to insufficient effect of one of them in isolation.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026