Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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 inflammatory cytokines and oxidative stress in the tear film.

The researchers intend to include 78 patients, divided into three intervention groups, who will be randomly assigned an eye drop with antioxidants, where the patient must apply one drop in each eye for 1 month.

In the study, the characteristics of the surface of the eye will be evaluated and tear samples will be taken from each eye, before and after the intervention with the eye drops. Subsequently, the clinical and sample results will be evaluated to compare the effects between them.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adolfo Daniel Rodriguez-Carrizalez
• Collaborator: Hospital Civil de Guadalajara

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