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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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ClinicalTrials.gov Identifier: NCT06017362
Recruitment Status : Recruiting
First Posted : August 30, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Barbara Burgos Blasco, Hospital San Carlos, Madrid

Study Description
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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).


Condition or disease Intervention/treatment Phase
Dry Eye Glaucoma Drug: Insulin Drug: Artificial tear Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 8, 2023
Estimated Primary Completion Date : February 8, 2025
Estimated Study Completion Date : February 8, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin
Topical insulin 1UI/ml 4 times a day
 Drug: Insulin
Topical insulin 1UI/ml 4 times a day
Placebo Comparator: Placebo (artificial tears)
Artificial tears 4 times a day
 Drug: Artificial tear
Artificial tears 4 times a day


Outcome Measures
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Primary Outcome Measures :
  1. Changes in dry eye symptoms from baseline to 6 months after treatment time [ Time Frame: From baseline to 6 months after treatment ]
    Dry eye symptoms will be evaluated using OSDI


Secondary Outcome Measures :
  1. Change of corneal staining from baseline to 6 months after treatment [ Time Frame: From baseline to 6 months after treatment ]
    Corneal staining will be evaluated on the slit-lamp and on slit-lamp images

  2. Change in corneal aesthesiometry from baseline to 6 months after treatment [ Time Frame: From baseline to 6 months after treatment ]
    Aesthesiometry will be evaluated using Cochet Bonnet

  3. Change in conjunctival hyperemia from baseline to 6 months after treatment [ Time Frame: From baseline to 6 months after treatment ]
    Conjunctival hyperemia will be evaluated using Keratograph

  4. Change in non-invasive tear film break-up time from baseline to 6 months after treatment [ Time Frame: From baseline to 6 months after treatment ]
    Non-invasive tear film break-up time will be evaluated using Keratograph

  5. Change in light dispersion from baseline to 6 months after treatment [ Time Frame: From baseline to 6 months after treatment ]
    Light dispersion will be evaluated using the Optical Quality Analysis System

  6. Change in cytokine levels from baseline to 6 months after treatment [ Time Frame: From baseline to 6 months after treatment ]
    Cytokine leves will be evaluated using immunoassay

  7. Change in therapeutic compliance from baseline to 6 months after treatment [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06017362


Contacts
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Contact: Barbara Burgos Blasco, MD, PhD +34 913303000 ext 3132 bburgos171@hotmail.com

Locations
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Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Barbara Burgos Blasco         
Sponsors and Collaborators
Barbara Burgos Blasco
Investigators
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Principal Investigator: Barbara Burgos Blasco, MD, PhD Hospital Clinico San Carlos
More Information
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Responsible Party: Barbara Burgos Blasco, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT06017362    
Other Study ID Numbers: 22/457-EC_M
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions