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

NCT06017362 | Recruiting Phase 4

• 1 other identifier: 22/457-EC_M
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Eye; Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of corneal staining from baseline to 6 months after treatment

  From baseline to 6 months after treatment

• Change in corneal aesthesiometry from baseline to 6 months after treatment

  From baseline to 6 months after treatment

• Change in conjunctival hyperemia from baseline to 6 months after treatment

  From baseline to 6 months after treatment

• Change in non-invasive tear film break-up time from baseline to 6 months after treatment

  From baseline to 6 months after treatment

• Change in light dispersion from baseline to 6 months after treatment

  From baseline to 6 months after treatment

Study Arms (2)

Insulin

EXPERIMENTAL

Topical insulin 1UI/ml 4 times a day

Drug: Insulin

Placebo (artificial tears)

PLACEBO COMPARATOR

Artificial tears 4 times a day

Drug: Artificial tear

Interventions

Insulin DRUG

Topical insulin 1UI/ml 4 times a day

Insulin

Artificial tear DRUG

Artificial tears 4 times a day

Placebo (artificial tears)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barbara Burgos Blasco: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Glaucoma

Interventions

Insulin; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Barbara Burgos Blasco, MD, PhD

  Hospital Clinico San Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Burgos Blasco, MD, PhD

CONTACT

+34 913303000; bburgos171@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: February 8, 2023
• Primary Completion: February 8, 2026
• Study Completion: February 8, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)