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Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy

Primary Purpose

Dry Eye Syndromes, Diabetic Retinopathy, Oxidative Stress

Status
Recruiting
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
VisuXL®
Lagricel PF®
Humylub PF®
Sponsored by
Adolfo Daniel Rodriguez-Carrizalez
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Q10 coenzyme, vitamin E and cross-linked hyaluronic acid

Sodium hyaluronate

Sodium hyaluronate and chondroitin sulfate

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline in levels of tumor necrosis factor alpha (TNF-a) in tear film at 30 days.
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Change from baseline in levels of interleukin 8 (IL-8)
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Change from baseline in levels of interleukin 6 (IL-6)
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in pg/mL.
Change from baseline in levels of interleukin 10 (IL-10)
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Changes from baseline in total antioxidant capacity in the tear film at 30 days.
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. Total antioxidant capacity concentration will be determined with colorimetric assay technique and reported in units called Trolox equivalents (TE), nmol/sample.
Change from baseline in lipoperoxides levels in tear film at 30 days.
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. Lipoperoxides concentration will be determined with colorimetric assay technique and reported in nmol/mL.

Secondary Outcome Measures

Change from baseline in the pattern of ocular surface staining with fluorescein sodium according to Oxford Scheme at 30 days.
Ocular surface staining with fluorescein sodium dye it will be assessed during slit lamp examination and it will be measure on a scale from 0 to 5 according to the Oxford scheme, with 5 being the most severe staining.
Change from baseline in the pattern of ocular surface staining with lissamine green according to Oxford Scheme at 30 days.
Ocular surface staining with lissamine green dye it will be assessed during slit lamp examination and it will be measure on a scale from 0 to 5 according to the Oxford scheme, with 5 being the most severe staining.
Change from baseline in the tear break-up time (TBUT) in seconds at 30 days.
It will be measured the time interval in seconds between a complete blink and the first appearance of a dry spot in the tear film after fluorescein sodium administration during slit-lamp examination, considering less than 10 seconds as abnormal.
Change from baseline in tear film osmolarity at 30 days.
It will be measured collecting a tear sample in each eye with TearLab® Test reporting osmolarity in milliosmol per liter (mOsm/L)
Change from baseline in tear secretion in mm with Schirmer I test at 30 days.
Tear secretion will be assessed with a graduated test strip placed on the lower eyelid margin without anesthesia, after five minutes, the strip is removed and the amount of wetting is measured in mm, less than 10 mm is considered abnormal.

Full Information

First Posted
May 30, 2022
Last Updated
June 23, 2022
Sponsor
Adolfo Daniel Rodriguez-Carrizalez
Collaborators
Hospital Civil de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT05429229
Brief Title
Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy
Official Title
Effect of Combined Antioxidant Therapy in Eye Drops on Inflammatory and Oxidative Stress Biomarkers in Tear Film in Patients With Diabetic Retinopathy and Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adolfo Daniel Rodriguez-Carrizalez
Collaborators
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Diabetic Retinopathy, Oxidative Stress, Tear Film Deficiency
Keywords
Dry Eye Disease, Oxidative Stress biomarkers, Inflammatory biomarkers, Tear film, Eye drops, Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial phase 2 A.
Masking
InvestigatorOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Q10 coenzyme, vitamin E and cross-linked hyaluronic acid
Arm Type
Experimental
Arm Description
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.
Arm Title
Sodium hyaluronate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sodium hyaluronate and chondroitin sulfate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VisuXL®
Other Intervention Name(s)
VisuXL tear drop
Intervention Description
It consists of a preservative-free eye drop composed of 100 mg cross-linked hyaluronic acid, 100 mg coenzyme Q10, 500 mg vitamin E TPGS (D-alpha-tocopheryl polyethylene glycol succinate), one drop is applied in each eye every 4 hours for a month.
Intervention Type
Drug
Intervention Name(s)
Lagricel PF®
Other Intervention Name(s)
Lagricel preservative free
Intervention Description
It consists of a preservative-free eye drop composed of sodium hyaluronate 0.4%, one drop is applied in each eye every 4 hours for a month.
Intervention Type
Drug
Intervention Name(s)
Humylub PF®
Other Intervention Name(s)
Humylub preservative free
Intervention Description
It consists of eye drops without preservatives composed of 0.1% sodium hyaluronate and 0.18% chondroitin sulfate, one drop is applied to each eye every 4 hours for a month.
Primary Outcome Measure Information:
Title
Change from baseline in levels of tumor necrosis factor alpha (TNF-a) in tear film at 30 days.
Description
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Time Frame
30 days
Title
Change from baseline in levels of interleukin 8 (IL-8)
Description
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Time Frame
30 days
Title
Change from baseline in levels of interleukin 6 (IL-6)
Description
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in pg/mL.
Time Frame
30 days
Title
Change from baseline in levels of interleukin 10 (IL-10)
Description
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. The cytokine concentration will be determined with multiplex bead immunoassays technique and reported in picogram per milliliter units (pg/mL)
Time Frame
30 days
Title
Changes from baseline in total antioxidant capacity in the tear film at 30 days.
Description
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. Total antioxidant capacity concentration will be determined with colorimetric assay technique and reported in units called Trolox equivalents (TE), nmol/sample.
Time Frame
30 days
Title
Change from baseline in lipoperoxides levels in tear film at 30 days.
Description
Tears will be collected with Drummond glass® micro capillary tubes without stimulation of tear secretion and placed in an eppendorf tube at -80 celsius degrees. Lipoperoxides concentration will be determined with colorimetric assay technique and reported in nmol/mL.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change from baseline in the pattern of ocular surface staining with fluorescein sodium according to Oxford Scheme at 30 days.
Description
Ocular surface staining with fluorescein sodium dye it will be assessed during slit lamp examination and it will be measure on a scale from 0 to 5 according to the Oxford scheme, with 5 being the most severe staining.
Time Frame
30 days
Title
Change from baseline in the pattern of ocular surface staining with lissamine green according to Oxford Scheme at 30 days.
Description
Ocular surface staining with lissamine green dye it will be assessed during slit lamp examination and it will be measure on a scale from 0 to 5 according to the Oxford scheme, with 5 being the most severe staining.
Time Frame
30 days
Title
Change from baseline in the tear break-up time (TBUT) in seconds at 30 days.
Description
It will be measured the time interval in seconds between a complete blink and the first appearance of a dry spot in the tear film after fluorescein sodium administration during slit-lamp examination, considering less than 10 seconds as abnormal.
Time Frame
30 days
Title
Change from baseline in tear film osmolarity at 30 days.
Description
It will be measured collecting a tear sample in each eye with TearLab® Test reporting osmolarity in milliosmol per liter (mOsm/L)
Time Frame
30 days
Title
Change from baseline in tear secretion in mm with Schirmer I test at 30 days.
Description
Tear secretion will be assessed with a graduated test strip placed on the lower eyelid margin without anesthesia, after five minutes, the strip is removed and the amount of wetting is measured in mm, less than 10 mm is considered abnormal.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Change from baseline severity of dry eye symptoms according the punctuation in Ocular Surface Disease Index (OSDI) at 30 days
Description
OSDI is a questionnaire that will be assessed on a scale of 0 to 100 to measure dry eye disease severity (normal, mild to moderate and severe) and effect on vission-related function.
Time Frame
30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adolfo D Rodríguez-Carrizalez, M.D./PhD
Phone
+52 33 10585200
Email
leinadkit@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
María G Martínez-Ruiz, M.D.
Phone
+52 33 31874939
Email
maria.mruiz@alumnos.udg.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adolfo D Rodriguez-Carrizalez, M.D/PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics,
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adolfo D. Rodriguez-Carrizalez, PhD
Phone
+52 33 10585200
Ext
33658
Email
adolfo.rodriguez@academicos.udg.mx
First Name & Middle Initial & Last Name & Degree
Maria G Martinez-Ruiz, MD
Phone
+52 33 31874939
Email
maria.mruiz@alumnos.udg.mx
First Name & Middle Initial & Last Name & Degree
Cecilia Olvera-Montaño, MD
First Name & Middle Initial & Last Name & Degree
Ana K López-Contreras, PBCh
First Name & Middle Initial & Last Name & Degree
Diana E Arévalo-Simental, MD

12. IPD Sharing Statement

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Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy

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