Status:
UNKNOWN
Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy
Lead Sponsor:
Adolfo Daniel Rodriguez-Carrizalez
Collaborating Sponsors:
Hospital Civil de Guadalajara
Conditions:
Dry Eye Syndromes
Diabetic Retinopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The main objective of our study is to evaluate the effect of eye drops with antioxidants on mild to moderate dry eye symptoms in patients with diabetic retinopathy, evaluating the levels of inflammato...
Detailed Description
Dry eye syndrome is a multifactorial disease where tear film homeostasis is lost, accompanied by ocular symptoms such as burning, blurred vision, foreign body sensation, ocular redness, itching, in wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05429229
Start Date
November 1 2021
End Date
January 31 2024
Last Update
June 29 2022
Active Locations (1)
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1
Institute of Experimental and Clinical Therapeutics,
Guadalajara, Jalisco, Mexico, 44340