Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco
Overview
- Phase
- Phase 4
- Intervention
- Insulin
- Conditions
- Not specified
- Sponsor
- Barbara Burgos Blasco
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Change of corneal staining from baseline to 6 months after treatment
- Status
- Completed
- Last Updated
- last month
Overview
Brief Summary
This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).
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.
Investigators
Barbara Burgos Blasco
Ophthalmologist
Hospital San Carlos, Madrid
Eligibility Criteria
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
- •Corneal staining under Oxford II
- •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, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations
- •Contact lenses
- •Other treatment besides artificial tears or hyaluronic acid gels
- •Visual acuity less than 0.1
- •Allergy or intolerance to any of the components included in the study
Arms & Interventions
Insulin
Topical insulin 1UI/ml 4 times a day
Intervention: Insulin
Cyclosporin
Cyclosporin 0,05% every 12 hours
Intervention: Cyclosporins
Artificial tears
Artificial tears 4 times a day
Intervention: Artificial tears
Outcomes
Primary Outcomes
Change of corneal staining from baseline to 6 months after treatment
Time Frame: From baseline to 6 months after treatment
Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator)
Secondary Outcomes
- Changes in dry eye symptoms from baseline to 6 months after treatment time(From baseline to 6 months after treatment)
- Changes in esthesiometry from baseline to 6 months after treatment time(From baseline to 6 months after treatment)
- Changes in tear rupture time from baseline to 6 months after treatment time(From baseline to 6 months after treatment)