Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Insulin Topical insulin 1UI/ml 4 times a day |
Drug: Insulin
Topical insulin 1UI/ml 4 times a day
|
| Placebo Comparator: Placebo (artificial tears) Artificial tears 4 times a day |
Drug: Artificial tear
Artificial tears 4 times a day
|
Outcome Measures
Primary Outcome Measures
- Changes in dry eye symptoms from baseline to 6 months after treatment time [From baseline to 6 months after treatment]
Dry eye symptoms will be evaluated using OSDI
Secondary Outcome Measures
- Change of corneal staining from baseline to 6 months after treatment [From baseline to 6 months after treatment]
Corneal staining will be evaluated on the slit-lamp and on slit-lamp images
- Change in corneal aesthesiometry from baseline to 6 months after treatment [From baseline to 6 months after treatment]
Aesthesiometry will be evaluated using Cochet Bonnet
- Change in conjunctival hyperemia from baseline to 6 months after treatment [From baseline to 6 months after treatment]
Conjunctival hyperemia will be evaluated using Keratograph
- Change in non-invasive tear film break-up time from baseline to 6 months after treatment [From baseline to 6 months after treatment]
Non-invasive tear film break-up time will be evaluated using Keratograph
- Change in light dispersion from baseline to 6 months after treatment [From baseline to 6 months after treatment]
Light dispersion will be evaluated using the Optical Quality Analysis System
- Change in cytokine levels from baseline to 6 months after treatment [From baseline to 6 months after treatment]
Cytokine leves will be evaluated using immunoassay
- Change in therapeutic compliance from baseline to 6 months after treatment [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
-
Patients ≥ 18 years at the screening visit.
-
Ocular hypertension or glaucoma controlled with hypotensive treatment
-
Diagnosis of dry eye
Exclusion Criteria:
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Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months
-
Changes in topical glaucoma treatment in the last 3 months
-
Severe dry eye requiring immediate treatment
-
Previous eye surgery, except cataract surgery more than 12 months ago
-
Laser procedures less than 6 months ago
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Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days
-
Eyelid disorders
-
Use of contact lenses
-
Other topical treatment other than dry eye and glaucoma
-
Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
-
Modifications in systemic immunosuppressive treatment in the last 6 months
-
History of alcohol or drug abuse
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Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
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Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).
-
Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinico San Carlos | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Barbara Burgos Blasco
Investigators
- Principal Investigator: Barbara Burgos Blasco, MD, PhD, Hospital Clinico San Carlos
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22/457-EC_M