INSULIN HUMAN for Persistent corneal epithelial defect

Inclusion criteria

• {"criterion_text":"- Age over 18 years\n- Diagnosis of persistent corneal epithelial defect\n- Signature of informed consent\n- Negative serology for HIV, HCV, HBV, HLTV and syphilis."}

Exclusion criteria

• {"criterion_text":"- Pregnancy or lactation\n- Extreme stromal thinning (residual corneal thickness less than 60% of total corneal thickness).\n- Severe limbal corneal ischaemia (grade IV or higher on the Dua scale, 6 hours or more of limbal ischaemia)."}

Primary endpoints

• {"endpoint_text":"- Closure or non-closure of the persistent epithelial defect, expressed as percentage of patients with complete re-epithelialisation.","definition_or_measurement_approach":"Expressed as percentage of patients with complete re-epithelialisation (binary outcome: complete re-epithelialisation vs not)."}
• {"endpoint_text":"- Closure rate (area of initial defect / days to epithelialisation, in mm2/day).","definition_or_measurement_approach":"Quantified as area of initial defect divided by days to epithelialisation, reported in mm2/day."}
• {"endpoint_text":"- Time to complete closure (in days) (closure in first two weeks of treatment: complete success; closure in first month of treatment: partial success).","definition_or_measurement_approach":"Measured in days from treatment start to complete closure; success categories: closure within first two weeks = complete success; closure within first month = partial success."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with insufficient response.","definition_or_measurement_approach":"Reported as percentage of enrolled patients meeting predefined criteria for insufficient response (not otherwise detailed in the record)."}
• {"endpoint_text":"- Percentage of patients with treatment failure.","definition_or_measurement_approach":"Reported as percentage of patients meeting predefined criteria for treatment failure (criteria not specified in the available record)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Exploratory analyses of associations between listed variables and treatment response; measurement approaches not specified in the available record."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"For patients receiving both treatments, report binary closure outcome and closure rate; specifics of timing/measurement not detailed in the record."}

Spain

Latest Decision Or Authorization Date

05-06-2025

Number Of Sites

2

Number Of Participants

234

Primary sponsor

Full Name

Hospital Clinico San Carlos

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain