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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Clinico San Carlos

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

26 Sep 2023 → ongoing

Decision date (initial)

2024-11-06

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III

External identifiers

EU CT number

2024-518818-53-00

EudraCT number

2022-003589-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of using insulin eye drops, comparing it with standard medical treatment (autologous serum eye drops), in the treatment of persistent epithelial defect of neurotrophic origin or secondary to chronic ocular surface diseases.

Secondary objectives 4

1. To evaluate the safety of using insulin eye drops in the treatment of persistent epithelial defects, comparing it with the safety of standard medical treatment (autologous serum eye drops).
2. To determine which variables may influence the success of the treatment (age, sex, etiology, comorbidity, etc.)
3. To determine the usefulness of the combination of insulin eye drops and autologous serum eye drops in persistent epithelial defects with insufficient response to either of them separately.
4. To describe the efficacy and safety of using insulin eye drops, comparing it with standard medical treatment (autologous serum eye drops), in the treatment of persistent epithelial defects of infectious origin.

Conditions and MedDRA coding

Persistent corneal epithelial defect.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age over 18 years
2. Diagnosis of persistent corneal epithelial defect
3. Signature of informed consent
4. Negative serology for HIV, HCV, HBV, HLTV and syphilis.

Exclusion criteria 3

1. Pregnancy or lactation
2. Extreme stromal thinning (residual corneal thickness less than 60% of total corneal thickness).
3. Severe limbal corneal ischaemia (grade IV or higher on the Dua scale, 6 hours or more of limbal ischaemia).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

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

Secondary endpoints 4

1. Percentage of patients with insufficient response.
2. Percentage of patients with treatment failure.
3. 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.
4. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Clinico San Carlos

Sponsor organisation

Hospital Clinico San Carlos

Address

Calle Del Profesor Martín Lagos S/n

City

Madrid

Postcode

28040

Country

Spain

Scientific contact point

Organisation

Hospital Clinico San Carlos

Contact name

Pedro Arriola Villalobos

Public contact point

Organisation

Hospital Clinico San Carlos

Contact name

Pedro Arriola Villalobos

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications