Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

2024-518376-31-00 Protocol 1INSULINAOJOSECO2021 Therapeutic use (Phase IV) Ended

Start 19 Oct 2022 · End 5 Nov 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 1INSULINAOJOSECO2021

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 120
Countries 1
Sites 1

Dry eye disease

The main objective is to investigate the efficacy of the use of insulin eye drops in the control of moderate-severe dry eye disease.

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
19 Oct 2022 → 5 Nov 2025
Decision date (initial)
2024-10-18
Transition trial
Yes
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518376-31-00
EudraCT number
2021-006801-31
ClinicalTrials.gov
NCT05692739

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The main objective is to investigate the efficacy of the use of insulin eye drops in the control of moderate-severe dry eye disease.

Secondary objectives 1

  1. The secondary objective is to investigate the efficacy of the use of insulin eye drops in the control of moderate-severe dry eye disease.

Conditions and MedDRA coding

Dry eye disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Patients older than 18 years
  2. Dry eye disease diagnosis
  3. Treatment with artificial tears or hyaluronic acid gels for at least 3 months
  4. Signed informed consent by the patient
  5. Staining equal to or greater than Oxford II

Exclusion criteria 18

  1. Under 18 years old
  2. Allergy or intolerance to any of the components included in the study
  3. Modifications in systemic immunosuppressive treatment
  4. Pregnancy or lactation
  5. Women of childbearing age who do not use a highly effective contraceptive method
  6. History of alcohol or drug abuse
  7. Participation in another clinical trial in the last 30 days
  8. Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)
  9. Corneal staining under Oxford II
  10. Treatment for dry eye disease other than artificial tears or hyaluronic acid gels
  11. Severe dry eye disease that requires immediate treatment
  12. Eye surgery in the last 6 months
  13. Other concomitant corneal pathology: cicatricial diseases of the ocular surface, uveitis, ocular infection in the last 90 days, trauma in the last 90 days
  14. Contact lenses
  15. Visual acuity less than 0.1
  16. Changes in topical treatment in the past 3 months
  17. Eyelid alterations: eyelid malposition, drainage alterations nasolacrimal or blink disorders
  18. Other topical treatment other than artificial tears and/or hyaluronic acid gel

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change of corneal staining from baseline to 6 months after treatment

Secondary endpoints 5

  1. Changes in dry eye symptoms from baseline to 6 months after treatment time
  2. Changes in esthesiometry from baseline to 6 months after treatment time
  3. Changes in tear rupture time from baseline to 6 months after treatment time
  4. Chnges in conjunctival hyperemia from baseline to 6 months of treatment
  5. Proportion of patients presenting adverse effects

Investigational products

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

Test 1

Insulin Human

SCP152623 · ATC

Active substance
Insulin Human
Substance synonyms
Insulin, human
Route of administration
OPHTHALMIC
Max daily dose
4 Other
Max total dose
732 Other
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
A10AB01 — INSULIN (HUMAN)
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Topical use

Comparator 1

Ciclosporin

SCP109571921 · ATC

Active substance
Ciclosporin
Substance synonyms
CYCLOSPORINE, CICLOSPORINE, CYCLOSPORIN
Route of administration
OPHTHALMIC
Max daily dose
2 Other
Max total dose
365 Other
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
S01XA18 — CICLOSPORIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Benzalkonium Chloride

SCP107133018 · ATC

Active substance
Benzalkonium Chloride
Substance synonyms
BENZALKONIUM CHLORATUM, ALKYLBENZYLDIMETHYLAMMONIUM CHLORIDE
Route of administration
OPHTHALMIC USE
Max daily dose
4 Other
Max total dose
732 Other
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
S01XA20 — ARTIFICIAL TEARS AND OTHER INDIFFERENT PREPARATIONS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Clinico San Carlos

7 Total trials 1 Recruiting 3 Ended
Academic / Non-commercial
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

CountryMS statusPlanned subjectsSites
Spain Ended 120 1
Rest of world — 0 —

Investigational sites

Spain

1 site · Ended
Hospital Clinico San Carlos
Ophthalmology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2022-10-19 2025-11-05 2022-10-19 2025-04-18

Results and documents

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

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Informe final
SUM-131292
 2026-04-28T21:44:41 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Informe final personas legas 2026-04-28T21:46:24 Submitted Laypersons Summary of Results

Documents 7 files

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

TypeTitleVersion
Laypersons summary of results (for publication) INFORME FINAL PERSONAS LEGAS INSULINAOJOSECO_REV 1
Protocol (for publication) D1_Protocol_01-INSULINA OJO SECO-2021_2024-518376-31-00 4
Recruitment arrangements (for publication) K2_Recruitment material poster 1
Subject information and informed consent form (for publication) L1_SIS and ICF_01-INSULINA OJO SECO-2021_2024-518376-31-00 4
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC _ciclosporin_INSULINA OJO SECO 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Actrapid_INSULINA OJO SECO 1
Summary of results (for publication) INFORME FINAL INSULINAOJOSECO_REV 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-06 Spain Acceptable
2024-10-18
 2024-10-18

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