Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy
Dry Eye Syndromes, Diabetic Retinopathy, Oxidative Stress
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye Disease, Oxidative Stress biomarkers, Inflammatory biomarkers, Tear film, Eye drops, Diabetic Retinopathy
Eligibility Criteria
Inclusion Criteria:
- Patients with type 2 diabetes, with presence of diabetic retinopathy in any of its stages without data on severity
- Patients who voluntarily give their informed consent.
- Patients who meet an Ocular Surface Disease Index (OSDI) score between 13-32 points (mild to moderate severity)
- Patients who meet one or more of the following:
- Tear film breakup time equal to or less than 10 seconds
- Corneal fluorescein staining with more than 5 sites
- Conjunctival staining with more than 9 sites.
- Non-smokers or history of inactive smoking > 6 months
- Metabolic criteria:
- Glycated hemoglobin equal to or less than 9%
- LDL less than or equal to 100 mg/dl
- Triglycerides less than or equal to 180 mg/dl
- Blood pressure less than or equal to 140/80 mm Hg
Exclusion Criteria:
- Patients with autoimmune diseases and/or Sjögren's disease
- Patients with neurodegenerative processes and/or cancer
- Present aggregate ophthalmological diagnosis of:
- Glaucoma
- Allergic, viral or bacterial conjunctivitis.
- Demodex
- Eye parasitic infections.
- Unresolved eye trauma
- Scarring diseases of the ocular surface
- Corneal or conjunctival ulcers.
- Filamentous keratitis, neurotrophic
- Bullous keratopathy
- Patients taking any of the following medications:
- Osmotic diuretics
- Alpha agonists
- NSAIDs, cannabinoids or opioids
- Benzodiazepines, selective serotonin reputate inhibitors, monoamine oxidate inhibitors
- nonlepromatous, antimalarials (Chloroquine / Hydroxychloroquine)
- Corticosteroids
Sites / Locations
- Institute of Experimental and Clinical Therapeutics,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Q10 coenzyme, vitamin E and cross-linked hyaluronic acid
Sodium hyaluronate
Sodium hyaluronate and chondroitin sulfate
This arm will administer eye drops with a combination of cross-linked hyaluronic acid, Q10 coenzyme and vitamin E, it will consist of 26 patients with diabetic retinopathy and mild to moderate dry eye syndrome. One drop will be instilled in each eye every 4 hours for a month.
This arm will administer eye drops with sodium hyaluronate, it will consist of 26 patients with diabetic retinopathy and mild to moderate dry eye syndrome. One drop will be instilled in each eye every 4 hours for a month.
This arm will administer eye drops with a combination of sodium hyaluronate and chondroitin sulfate, it will consist of 26 patients with diabetic retinopathy and mild to moderate dry eye syndrome. One drop will be instilled in each eye every 4 hours for a month.