Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors

Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Hipotensores Tópicos

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).

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Dry Eye
• Intervention / Treatment: Drug: Insulin; Drug: Artificial tear

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Barbara Burgos Blasco, MD, PhD; Phone Number: 3132 +34 913303000; Email: bburgos171@hotmail.com

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Barbara Burgos Blasco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in dry eye symptoms from baseline to 6 months after treatment time	Dry eye symptoms will be evaluated using OSDI	From baseline to 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to 6 months after treatment
Change in corneal aesthesiometry from baseline to 6 months after treatment	Aesthesiometry will be evaluated using Cochet Bonnet	From baseline to 6 months after treatment
Change in conjunctival hyperemia from baseline to 6 months after treatment	Conjunctival hyperemia will be evaluated using Keratograph	From baseline to 6 months after treatment
Change in cytokine levels from baseline to 6 months after treatment	Cytokine leves will be evaluated using immunoassay	From baseline to 6 months after treatment
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	From baseline to 6 months after treatment
Change in light dispersion from baseline to 6 months after treatment	Light dispersion will be evaluated using the Optical Quality Analysis System	From baseline to 6 months after treatment
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.	From baseline to 6 months after treatment

Collaborators and Investigators

• Sponsor: Barbara Burgos Blasco
• Investigators: Principal Investigator: Barbara Burgos Blasco, MD, PhD, Hospital Clinico San Carlos

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Estimated): February 8, 2026
• Study Completion (Estimated): February 8, 2026

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions; Lubricant Eye Drops
• Other Study ID Numbers: 22/457-EC_M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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