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

Primary Purpose

Dry Eye, Glaucoma

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Insulin
Artificial tear
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 who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures. Patients ≥ 18 years at the screening visit. Ocular hypertension or glaucoma controlled with hypotensive treatment Diagnosis of dry eye Exclusion Criteria: Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months Changes in topical glaucoma treatment in the last 3 months Severe dry eye requiring immediate treatment Previous eye surgery, except cataract surgery more than 12 months ago Laser procedures less than 6 months ago Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days Eyelid disorders Use of contact lenses Other topical treatment other than dry eye and glaucoma Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients Modifications in systemic immunosuppressive treatment in the last 6 months History of alcohol or drug abuse Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit. 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). 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.

Sites / Locations

  • Hospital Clinico San CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Insulin

Placebo (artificial tears)

Arm Description

Topical insulin 1UI/ml 4 times a day

Artificial tears 4 times a day

Outcomes

Primary Outcome Measures

Changes in dry eye symptoms from baseline to 6 months after treatment time
Dry eye symptoms will be evaluated using OSDI

Secondary 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
Change in corneal aesthesiometry from baseline to 6 months after treatment
Aesthesiometry will be evaluated using Cochet Bonnet
Change in conjunctival hyperemia from baseline to 6 months after treatment
Conjunctival hyperemia will be evaluated using Keratograph
Change in non-invasive tear film break-up time from baseline to 6 months after treatment
Non-invasive tear film break-up time will be evaluated using Keratograph
Change in light dispersion from baseline to 6 months after treatment
Light dispersion will be evaluated using the Optical Quality Analysis System
Change in cytokine levels from baseline to 6 months after treatment
Cytokine leves will be evaluated using immunoassay
Change in therapeutic compliance from baseline to 6 months after treatment
Therapeutic compliance will be evaluated using Medication adherence rating scale (MARS). The total score ranges from 0-10 with a higher score indicating better adherence.

Full Information

First Posted
August 24, 2023
Last Updated
September 1, 2023
Sponsor
Barbara Burgos Blasco
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1. Study Identification

Unique Protocol Identification Number
NCT06017362
Brief Title
Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors
Official Title
Ensayo clínico Para Determinar la Eficacia y Seguridad Del Colirio de Insulina en el Tratamiento Del Ojo Seco en Pacientes Con Hipotensores tópicos
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
February 8, 2025 (Anticipated)
Study Completion Date
February 8, 2025 (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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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). The main question aims to answer whether glaucoma patients treated with topical hypotensors could benefit from the use of insulin eye drops for the treatment of dry eye. Participants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).
Detailed Description
Patients will be recruited in Madrid. Patients with dry eye disease and topical glaucoma treatment 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, Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin
Arm Type
Experimental
Arm Description
Topical insulin 1UI/ml 4 times a day
Arm Title
Placebo (artificial tears)
Arm Type
Placebo Comparator
Arm Description
Artificial tears 4 times a day
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Topical insulin 1UI/ml 4 times a day
Intervention Type
Drug
Intervention Name(s)
Artificial tear
Intervention Description
Artificial tears 4 times a day
Primary 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
Secondary 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
Time Frame
From baseline to 6 months after treatment
Title
Change in corneal aesthesiometry from baseline to 6 months after treatment
Description
Aesthesiometry will be evaluated using Cochet Bonnet
Time Frame
From baseline to 6 months after treatment
Title
Change in conjunctival hyperemia from baseline to 6 months after treatment
Description
Conjunctival hyperemia will be evaluated using Keratograph
Time Frame
From baseline to 6 months after treatment
Title
Change in non-invasive tear film break-up time from baseline to 6 months after treatment
Description
Non-invasive tear film break-up time will be evaluated using Keratograph
Time Frame
From baseline to 6 months after treatment
Title
Change in light dispersion from baseline to 6 months after treatment
Description
Light dispersion will be evaluated using the Optical Quality Analysis System
Time Frame
From baseline to 6 months after treatment
Title
Change in cytokine levels from baseline to 6 months after treatment
Description
Cytokine leves will be evaluated using immunoassay
Time Frame
From baseline to 6 months after treatment
Title
Change in therapeutic compliance from baseline to 6 months after treatment
Description
Therapeutic compliance will be evaluated using Medication adherence rating scale (MARS). The total score ranges from 0-10 with a higher score indicating better adherence.
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 who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures. Patients ≥ 18 years at the screening visit. Ocular hypertension or glaucoma controlled with hypotensive treatment Diagnosis of dry eye Exclusion Criteria: Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months Changes in topical glaucoma treatment in the last 3 months Severe dry eye requiring immediate treatment Previous eye surgery, except cataract surgery more than 12 months ago Laser procedures less than 6 months ago Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days Eyelid disorders Use of contact lenses Other topical treatment other than dry eye and glaucoma Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients Modifications in systemic immunosuppressive treatment in the last 6 months History of alcohol or drug abuse Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit. 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Burgos Blasco, MD, PhD
Phone
+34 913303000
Ext
3132
Email
bburgos171@hotmail.com
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
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Burgos Blasco

12. IPD Sharing Statement

Plan to Share IPD
No

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

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