Hospital Clinico San Carlos
Madrid, 28040, Spain
Location status: Recruiting
Location contact
Barbara Burgos Blasco
CONTACT
NCT Number: NCT06017362
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Madrid, 28040, Spain
Location status: Recruiting
Barbara Burgos Blasco
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Topical insulin 1UI/ml 4 times a day
Artificial tears 4 times a day
Time frame: From baseline to 6 months after treatment
Dry eye symptoms will be evaluated using OSDI
Time frame: From baseline to 6 months after treatment
Corneal staining will be evaluated on the slit-lamp and on slit-lamp images
Time frame: From baseline to 6 months after treatment
Aesthesiometry will be evaluated using Cochet Bonnet
Time frame: From baseline to 6 months after treatment
Conjunctival hyperemia will be evaluated using Keratograph
Time frame: From baseline to 6 months after treatment
Non-invasive tear film break-up time will be evaluated using Keratograph
Time frame: From baseline to 6 months after treatment
Light dispersion will be evaluated using the Optical Quality Analysis System
Time frame: From baseline to 6 months after treatment
Cytokine leves will be evaluated using immunoassay
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Barbara Burgos Blasco
Other
Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Hipotensores Tópicos
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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