Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Hipotensores Tópicos
Overview
- Phase
- Phase 4
- Intervention
- Insulin
- Conditions
- Dry Eye
- Sponsor
- Barbara Burgos Blasco
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes in dry eye symptoms from baseline to 6 months after treatment time
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
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.
Investigators
Barbara Burgos Blasco
Principal Investigator
Hospital San Carlos, Madrid
Eligibility 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
Arms & Interventions
Insulin
Topical insulin 1UI/ml 4 times a day
Intervention: Insulin
Placebo (artificial tears)
Artificial tears 4 times a day
Intervention: Artificial tear
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Change in cytokine levels from baseline to 6 months after treatment(From baseline to 6 months after treatment)
- Change in therapeutic compliance from baseline to 6 months after treatment(From baseline to 6 months after treatment)