CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS AND SAFETY OF TOPICAL INSULIN IN THE TREATMENT OF PERSISTENT CORNEAL EPITHELIAL DEFECTS

MULTICENTRIC, CONTROLLED, RANDOMIZED, WITH BLIND OBSERVER CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF INSULIN EYE DROPS (1 IU/ml) IN THE TREATMENT OF PERSISTENT CORNEAL EPITHELIAL DEFECTS

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003589-19-ES

Enrollment

234

Registered

2023-02-14

Start date

2023-03-14

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

PERSISTENT EPITHELIAL CORNEAL DEFECT

Interventions

Trade Name: Actrapid Pharmaceutical Form: INN or Proposed INN: insulin CAS Number: 9004-10-8 Current Sponsor code: insulin Other descriptive name: INSULIN Concentration unit: U/ml unit(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Older than 18 years - Diagnosis of persistent corneal epithelial defect - Signed informed consent - Negative serology for HIV, HCV, HBV, HLTV and lues Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 234 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy or lactation - Extreme stromal thinning (residual corneal thickness less than 60%) - Severe ischemia of the corneal limbus (grade IV or higher on the Dua scale, 6 hours or more of limbal ischemia).

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of topical insulin in the treatment of persistent corneal epithelial defects, compared to 20% autologous serum.;Secondary Objective: Not applicable;Primary end point(s): No epithelial defect;Timepoint(s) of evaluation of this end point: A visit will be made every three to five days until week 4 of treatment and once every week until six weeks, to continue with a visit every two weeks until three months of follow-up.	—

Measure

Time frame

Main Objective: To assess the efficacy of topical insulin in the treatment of persistent corneal epithelial defects, compared to 20% autologous serum.;Secondary Objective: Not applicable;Primary end point(s): No epithelial defect;Timepoint(s) of evaluation of this end point: A visit will be made every three to five days until week 4 of treatment and once every week until six weeks, to continue with a visit every two weeks until three months of follow-up.

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: All visits	—

Countries

Spain

Contacts

Public ContactPedro Arriola-Villalobos

Pedro Arriola-Villalobos

pedro.arriola@salud.madrid.org+34913303132

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026