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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
116
see arm description
see arm description
see arm description
Hospital Clinico San Carlos
Madrid, Spain
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 (masked evaluator)
Time frame: From baseline to 6 months after treatment
Changes in dry eye symptoms from baseline to 6 months after treatment time
Dry eye symptoms will be evaluated using OSDI
Time frame: From baseline to 6 months after treatment
Changes in esthesiometry from baseline to 6 months after treatment time
Esthesiometry will be evaluated using an esthesiometer
Time frame: From baseline to 6 months after treatment
Changes in tear rupture time from baseline to 6 months after treatment time
Tear rupture time will be evaluated using the Keratograph (Oculus)
Time frame: From baseline to 6 months after treatment
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