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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin | Experimental | Topical insulin 1UI/ml 4 times a day |
|
| Cyclosporin | Active Comparator | Cyclosporin 0,05% every 12 hours |
|
| Artificial tears | Placebo Comparator | Artificial tears 4 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | see arm description |
| |
| Cyclosporins |
| 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 (masked evaluator) | From baseline to 6 months after treatment |
| 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 |
| Changes in esthesiometry from baseline to 6 months after treatment time |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34407296 | Background | Diaz-Valle D, Burgos-Blasco B, Rego-Lorca D, Puebla-Garcia V, Perez-Garcia P, Benitez-Del-Castillo JM, Herrero-Vanrell R, Vicario-de-la-Torre M, Gegundez-Fernandez JA. Comparison of the efficacy of topical insulin with autologous serum eye drops in persistent epithelial defects of the cornea. Acta Ophthalmol. 2022 Jun;100(4):e912-e919. doi: 10.1111/aos.14997. Epub 2021 Aug 18. | |
| 32951459 |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D003524 | Cyclosporins |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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This will be a randomized controlled trial for the treatment of dry eye disease with three arms: topical insulin, topical cyclosporin (gold standard) and artificial tears (placebo)
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| Drug |
see arm description |
|
| Artificial tears | Drug | see arm description |
|
Esthesiometry will be evaluated using an esthesiometer
| 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) | From baseline to 6 months after treatment |
| Background |
| Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21. |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| 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 |