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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin | Experimental | Topical insulin 1UI/ml 4 times a day |
|
| Placebo (artificial tears) | Placebo Comparator | Artificial tears 4 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Topical insulin 1UI/ml 4 times a day |
| |
| Artificial tear |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in dry eye symptoms from baseline to 6 months after treatment time | Dry eye symptoms will be evaluated using OSDI | From baseline to 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to 6 months after treatment |
| Change in corneal aesthesiometry from baseline to 6 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Burgos Blasco, MD, PhD | Contact | +34 913303000 | 3132 | bburgos171@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Burgos Blasco, MD, PhD | Hospital Clinico San Carlos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Artificial tears 4 times a day |
|
Aesthesiometry will be evaluated using Cochet Bonnet |
| From baseline to 6 months after treatment |
| Change in conjunctival hyperemia from baseline to 6 months after treatment | Conjunctival hyperemia will be evaluated using Keratograph | From baseline to 6 months after treatment |
| Change in non-invasive tear film break-up time from baseline to 6 months after treatment | Non-invasive tear film break-up time will be evaluated using Keratograph | From baseline to 6 months after treatment |
| Change in light dispersion from baseline to 6 months after treatment | Light dispersion will be evaluated using the Optical Quality Analysis System | From baseline to 6 months after treatment |
| Change in cytokine levels from baseline to 6 months after treatment | Cytokine leves will be evaluated using immunoassay | From baseline to 6 months after treatment |
| Change in therapeutic compliance 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. | From baseline to 6 months after treatment |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |