Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    78
  • sponsor
    Adolfo Daniel Rodriguez-Carrizalez
Updated on 15 July 2022
diabetes
type 2 diabetes
hyaluronic acid

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.

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 which tear film instability and hyperosmolarity, causing inflammation of the ocular surface, endothelial damage and neurosensory alterations.

Worldwide, in patients with diabetic retinopathy it has a prevalence of 54%, however in Mexico, only a prevalence of 41% has been described in the diabetic population, without having reports of prevalence in patients with diabetic retinopathy.

The state of chronic hyperglycemia in diabetes mellitus causes neuropathic corneal damage and dysfunction of the meibomian glands, this promotes a decrease in tear production, establishing dysfunction of the tear film and a state of hyperosmolarity in it, the latter induces activation of inflammatory mediators and release of proinflammatory cytokines that generate more damage to the corneal surface, entering a vicious cycle of tear film instability.

Likewise, the preexisting state of oxidative stress in patients with diabetic retinopathy, where there is an imbalance between the production and degradation of reactive oxygen species, contributes to the induction of changes in the corneal surface and tear film dysfunction.

Dry eye treatment is focused on the characteristics of the tear film and the characteristics of the ocular surface, with the aim of controlling and improving symptoms, with the use of different formulations and tolerability profiles. However, these are not adequate to reduce the effect of the inflammatory state and oxidative stress present in the tear film and the ocular surface, causing the patient's visual quality to worsen.

The researchers intend to assess whether antioxidant therapy in eye drops influences levels of oxidative stress and inflammatory markers in the tear film.

Details
Condition Dry Eye Syndromes, Diabetic Retinopathy, Oxidative Stress, Tear Film Deficiency
Treatment VisuXL®, Lagricel PF®, Humylub PF®
Clinical Study IdentifierNCT05429229
SponsorAdolfo Daniel Rodriguez-Carrizalez
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

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
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