Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors

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

8 Feb 2023 → 27 Mar 2026

Decision date (initial)

2024-10-16

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518407-22-00

EudraCT number

2022-002434-13

ClinicalTrials.gov

NCT06017362

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears).

Conditions and MedDRA coding

Dry eye disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
2. Patients ≥ 18 years at the screening visit.
3. Ocular hypertension or glaucoma controlled with hypotensive treatment
4. Diagnosis of dry eye

Exclusion criteria 15

1. Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months
2. Changes in topical glaucoma treatment in the last 3 months
3. Severe dry eye requiring immediate treatment
4. Previous eye surgery, except cataract surgery more than 12 months ago
5. Laser procedures less than 6 months ago
6. Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days
7. Eyelid disorders
8. Use of contact lenses
9. Other topical treatment other than dry eye and glaucoma
10. Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
11. Modifications in systemic immunosuppressive treatment in the last 6 months
12. History of alcohol or drug abuse
13. Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
14. Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).
15. Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Changes in dry eye symptoms from baseline to 6 months after treatment time

Secondary endpoints 8

1. Change of corneal staining from baseline to 6 months after treatment
2. Change in corneal aesthesiometry from baseline to 6 months after treatment
3. Change in conjunctival hyperemia from baseline to 6 months after treatment
4. Change in non-invasive tear film break-up time from baseline to 6 months after treatment
5. Change in light dispersion from baseline to 6 months after treatment
6. Change in cytokine levels from baseline to 6 months after treatment
7. Changes in therapeutic compliance with hypotensive treatment
8. Proportion of patients presenting adverse effects

Investigational products

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

Test 1

Placebo 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

Barbara Burgos Blasco

Public contact point

Organisation

Hospital Clinico San Carlos

Contact name

Barbara Burgos Blasco

Locations

1 EU/EEA country · 1 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 4 files

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

Application history

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