Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

Phase 4

Active, not recruiting

• Conditions: Dry eye disease
• Interventions: Drug: Insulin; Drug: Artificial tears; Drug: Cyclosporins

• Registration Number: 2024-518376-31-00
• Lead Sponsor: Hospital Clinico San Carlos

Brief Summary

The main objective is to investigate the efficacy of the use of insulin eye drops in the control of moderate-severe dry eye disease.

Detailed Description

Patients will be recruited in Madrid. Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.

Study Timeline

• Study First Posted: 2024-10-18
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Patients older than 18 years

Dry eye disease diagnosis

Treatment with artificial tears or hyaluronic acid gels for at least 3 months

Signed informed consent by the patient

Staining equal to or greater than Oxford II

Exclusion Criteria

Under 18 years old

Treatment for dry eye disease other than artificial tears or hyaluronic acid gels

Severe dry eye disease that requires immediate treatment

Eye surgery in the last 6 months

Other concomitant corneal pathology: cicatricial diseases of the ocular surface, uveitis, ocular infection in the last 90 days, trauma in the last 90 days

Contact lenses

Visual acuity less than 0.1

Changes in topical treatment in the past 3 months

Eyelid alterations: eyelid malposition, drainage alterations nasolacrimal or blink disorders

Other topical treatment other than artificial tears and/or hyaluronic acid gel

Allergy or intolerance to any of the components included in the study

Modifications in systemic immunosuppressive treatment

Pregnancy or lactation

Women of childbearing age who do not use a highly effective contraceptive method

History of alcohol or drug abuse

Participation in another clinical trial in the last 30 days

Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)

Corneal staining under Oxford II

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin	Insulin	Topical insulin 1UI/ml 4 times a day
Artificial tears	Artificial tears	Artificial tears 4 times a day
Cyclosporin	Cyclosporins	Cyclosporin 0,05% every 12 hours

Primary Outcome Measures

Name	Time	Method
Change of corneal staining from baseline to 6 months after treatment		Change of corneal staining from baseline to 6 months after treatment

Secondary Outcome Measures

Name	Time	Method
Changes in dry eye symptoms from baseline to 6 months after treatment time		Changes in dry eye symptoms from baseline to 6 months after treatment time
Changes in esthesiometry from baseline to 6 months after treatment time		Changes in esthesiometry from baseline to 6 months after treatment time
Changes in tear rupture time from baseline to 6 months after treatment time		Changes in tear rupture time from baseline to 6 months after treatment time
Chnges in conjunctival hyperemia from baseline to 6 months of treatment		Chnges in conjunctival hyperemia from baseline to 6 months of treatment
Proportion of patients presenting adverse effects		Proportion of patients presenting adverse effects

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos

🇪🇸Madrid, Spain

Barbara Burgos Blasco

Site contact

913303000

barbara.burgos@salud.madrid.org