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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017362
• Other study ID #: 22/457-EC_M
• Status: Recruiting
• Phase: Phase 4
• Start date: February 8, 2023
• Est. completion date: February 8, 2025

Study information

• Verified date: September 2023
• Source: Hospital San Carlos, Madrid
• Contact: Barbara Burgos Blasco, MD, PhD
• Phone: +34 913303000
• Email: bburgos171[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 8, 2025
• Est. primary completion date: February 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Glaucoma
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Insulin
Topical insulin 1UI/ml 4 times a day
• Artificial tear
Artificial tears 4 times a day

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Burgos Blasco

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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