Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors
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ClinicalTrials.gov Identifier: NCT06017362 |
Recruitment Status :
Recruiting
First Posted : August 30, 2023
Last Update Posted : September 6, 2023
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Glaucoma | Drug: Insulin Drug: Artificial tear | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ensayo clínico Para Determinar la Eficacia y Seguridad Del Colirio de Insulina en el Tratamiento Del Ojo Seco en Pacientes Con Hipotensores tópicos |
Actual Study Start Date : | February 8, 2023 |
Estimated Primary Completion Date : | February 8, 2025 |
Estimated Study Completion Date : | February 8, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Insulin
Topical insulin 1UI/ml 4 times a day
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Drug: Insulin
Topical insulin 1UI/ml 4 times a day |
Placebo Comparator: Placebo (artificial tears)
Artificial tears 4 times a day
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Drug: Artificial tear
Artificial tears 4 times a day |
- Changes in dry eye symptoms from baseline to 6 months after treatment time [ Time Frame: From baseline to 6 months after treatment ]Dry eye symptoms will be evaluated using OSDI
- Change of corneal staining from baseline to 6 months after treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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
- 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
- Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06017362
Contact: Barbara Burgos Blasco, MD, PhD | +34 913303000 ext 3132 | bburgos171@hotmail.com |
Spain | |
Hospital Clinico San Carlos | Recruiting |
Madrid, Spain, 28040 | |
Contact: Barbara Burgos Blasco |
Principal Investigator: | Barbara Burgos Blasco, MD, PhD | Hospital Clinico San Carlos |
Responsible Party: | Barbara Burgos Blasco, Principal Investigator, Hospital San Carlos, Madrid |
ClinicalTrials.gov Identifier: | NCT06017362 |
Other Study ID Numbers: |
22/457-EC_M |
First Posted: | August 30, 2023 Key Record Dates |
Last Update Posted: | September 6, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Diseases Lacrimal Apparatus Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Lubricant Eye Drops Ophthalmic Solutions Pharmaceutical Solutions |