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

Primary Purpose

Dry Eye, Insulin

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Insulin
Cyclosporins
Artificial tears
Sponsored by
Barbara Burgos Blasco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients older than 18 years Dry eye disease diagnosis Treatment with artificial tears or hyaluronic acid gels for at least 3 months Signed informed consent by the patient Staining equal to or greater than Oxford II Exclusion Criteria: Under 18 years old Corneal staining under Oxford II Treatment for dry eye disease other than artificial tears or hyaluronic acid gels Severe dry eye disease that requires immediate treatment Eye surgery in the last 6 months Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations Contact lenses Other treatment besides artificial tears or hyaluronic acid gels Visual acuity less than 0.1 Allergy or intolerance to any of the components included in the study Modifications in systemic immunosuppressive treatment Pregnancy or lactation Women of childbearing age who do not use a highly effective contraceptive method History of alcohol or drug abuse Participation in another clinical trial in the last 30 days 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)

Sites / Locations

  • Hospital Clinico San CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Insulin

Cyclosporin

Artificial tears

Arm Description

Topical insulin 1UI/ml 4 times a day

Cyclosporin 0,05% every 12 hours

Artificial tears 4 times a day

Outcomes

Primary Outcome Measures

Change of corneal staining from baseline to 6 months after treatment
Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator)

Secondary Outcome Measures

Changes in dry eye symptoms from baseline to 6 months after treatment time
Dry eye symptoms will be evaluated using OSDI
Changes in esthesiometry from baseline to 6 months after treatment time
Esthesiometry will be evaluated using an esthesiometer
Changes in tear rupture time from baseline to 6 months after treatment time
Tear rupture time will be evaluated using the Keratograph (Oculus)

Full Information

First Posted
January 10, 2023
Last Updated
January 18, 2023
Sponsor
Barbara Burgos Blasco
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1. Study Identification

Unique Protocol Identification Number
NCT05692739
Brief Title
Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye
Official Title
Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barbara Burgos Blasco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).
Detailed Description
Patients will be recruited in Madrid. Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial for the treatment of dry eye disease with three arms: topical insulin, topical cyclosporin (gold standard) and artificial tears (placebo)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin
Arm Type
Experimental
Arm Description
Topical insulin 1UI/ml 4 times a day
Arm Title
Cyclosporin
Arm Type
Active Comparator
Arm Description
Cyclosporin 0,05% every 12 hours
Arm Title
Artificial tears
Arm Type
Placebo Comparator
Arm Description
Artificial tears 4 times a day
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
see arm description
Intervention Type
Drug
Intervention Name(s)
Cyclosporins
Intervention Description
see arm description
Intervention Type
Drug
Intervention Name(s)
Artificial tears
Intervention Description
see arm description
Primary Outcome Measure Information:
Title
Change of corneal staining from baseline to 6 months after treatment
Description
Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator)
Time Frame
From baseline to 6 months after treatment
Secondary Outcome Measure Information:
Title
Changes in dry eye symptoms from baseline to 6 months after treatment time
Description
Dry eye symptoms will be evaluated using OSDI
Time Frame
From baseline to 6 months after treatment
Title
Changes in esthesiometry from baseline to 6 months after treatment time
Description
Esthesiometry will be evaluated using an esthesiometer
Time Frame
From baseline to 6 months after treatment
Title
Changes in tear rupture time from baseline to 6 months after treatment time
Description
Tear rupture time will be evaluated using the Keratograph (Oculus)
Time Frame
From baseline to 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years Dry eye disease diagnosis Treatment with artificial tears or hyaluronic acid gels for at least 3 months Signed informed consent by the patient Staining equal to or greater than Oxford II Exclusion Criteria: Under 18 years old Corneal staining under Oxford II Treatment for dry eye disease other than artificial tears or hyaluronic acid gels Severe dry eye disease that requires immediate treatment Eye surgery in the last 6 months Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations Contact lenses Other treatment besides artificial tears or hyaluronic acid gels Visual acuity less than 0.1 Allergy or intolerance to any of the components included in the study Modifications in systemic immunosuppressive treatment Pregnancy or lactation Women of childbearing age who do not use a highly effective contraceptive method History of alcohol or drug abuse Participation in another clinical trial in the last 30 days 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Burgos Blasco, MD, PhD
Phone
+34 913303000
Ext
3132
Email
barbara.burgos@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Burgos Blasco, MD, PhD
Organizational Affiliation
Hospital Clinico San Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Burgos Blasco, MD, PhD
Phone
+34 9133303000
Ext
3132
Email
barbara.burgos@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34407296
Citation
Diaz-Valle D, Burgos-Blasco B, Rego-Lorca D, Puebla-Garcia V, Perez-Garcia P, Benitez-Del-Castillo JM, Herrero-Vanrell R, Vicario-de-la-Torre M, Gegundez-Fernandez JA. Comparison of the efficacy of topical insulin with autologous serum eye drops in persistent epithelial defects of the cornea. Acta Ophthalmol. 2022 Jun;100(4):e912-e919. doi: 10.1111/aos.14997. Epub 2021 Aug 18.
Results Reference
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PubMed Identifier
32951459
Citation
Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.
Results Reference
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Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

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