Dry Eye SyndromesPhase 2NCT05429229
Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy
A Phase 2 study testing VisuXL®, Lagricel PF® and Humylub PF® in people with Dry Eye Syndromes and Diabetic Retinopathy, run by Adolfo Daniel Rodriguez-Carrizalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye Syndromes, Diabetic Retinopathy, Oxidative Stress
- What is being tested?
- VisuXL®, Lagricel PF® and Humylub PF®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2021to 31 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Institute of Experimental and Clinical Therapeutics,
Guadalajara, Jalisco, 44340
Adolfo D. Rodriguez-Carrizalez, PhD, +52 33 10585200 ext. 33658, adolfo.rodriguez@academicos.udg.mx
Maria G Martinez-Ruiz, MD, +52 33 31874939, maria.mruiz@alumnos.udg.mx
About this study
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
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.
Read the 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.
- Being tested
- VisuXL®, Lagricel PF®, Humylub PF®
- Keywords
- Dry Eye Disease, Oxidative Stress biomarkers, Inflammatory biomarkers, Tear film, Eye drops, Diabetic Retinopathy
- Medical subject headings
- Dry Eye Syndromes, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisuXL®Drug
Also called VisuXL tear drop
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.
Lagricel PF®Drug
Also called Lagricel preservative free
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.
Humylub PF®Drug
Also called Humylub preservative free
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.
| Study group | Role | What they receive |
|---|---|---|
| Q10 coenzyme, vitamin E and cross-linked hyaluronic acid | Experimental | 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. Receives: Drug: VisuXL® |
| Sodium hyaluronate | Active comparator | 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. Receives: Drug: Lagricel PF® |
| Sodium hyaluronate and chondroitin sulfate | Active comparator | 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. Receives: Drug: Humylub PF® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
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)
Measured: 30 days
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.
Measured: 30 days
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)
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Secondary outcomes (5)
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
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)
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial phase 2 A.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adolfo Daniel Rodriguez-Carrizalez
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Civil de Guadalajara
- Responsible party
- Sponsor-investigator, Adolfo Daniel Rodriguez-Carrizalez, University of Guadalajara
- Investigators
- Adolfo D Rodriguez-Carrizalez, M.D/PhD, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429229
- Sponsor's protocol ID
- OSRD-20200831-1
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez-Contreras AK, Martinez-Ruiz MG, Olvera-Montano C, Robles-Rivera RR, Arevalo-Simental DE, Castellanos-Gonzalez JA, Hernandez-Chavez A, Huerta-Olvera SG, Cardona-Munoz EG, Rodriguez-Carrizalez AD. Importance of the Use of Oxidative Stress Biomarkers and Inflammatory Profile in Aqueous and Vitreous Humor in Diabetic Retinopathy. Antioxidants (Basel). 2020 Sep 20;9(9):891. doi: 10.3390/antiox9090891.
PubMed 32962301Pastor-Maldonado CJ, Suarez-Rivero JM, Povea-Cabello S, Alvarez-Cordoba M, Villalon-Garcia I, Munuera-Cabeza M, Suarez-Carrillo A, Talaveron-Rey M, Sanchez-Alcazar JA. Coenzyme Q10: Novel Formulations and Medical Trends. Int J Mol Sci. 2020 Nov 10;21(22):8432. doi: 10.3390/ijms21228432.
PubMed 33182646Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.
PubMed 28777385Najafi L, Malek M, Valojerdi AE, Aghili R, Khamseh ME, Fallah AE, Tokhmehchi MR, Behrouz MJ. Dry eye and its correlation to diabetes microvascular complications in people with type 2 diabetes mellitus. J Diabetes Complications. 2013 Sep-Oct;27(5):459-62. doi: 10.1016/j.jdiacomp.2013.04.006. Epub 2013 May 30.
PubMed 23726741Graue-Hernandez EO, Serna-Ojeda JC, Estrada-Reyes C, Navas A, Arrieta-Camacho J, Jimenez-Corona A. Dry eye symptoms and associated risk factors among adults aged 50 or more years in Central Mexico. Salud Publica Mex. 2018 Sep-Oct;60(5):520-527. doi: 10.21149/9024.
PubMed 30550113Gao Y, Zhang Y, Ru YS, Wang XW, Yang JZ, Li CH, Wang HX, Li XR, Li B. Ocular surface changes in type II diabetic patients with proliferative diabetic retinopathy. Int J Ophthalmol. 2015 Apr 18;8(2):358-64. doi: 10.3980/j.issn.2222-3959.2015.02.26. eCollection 2015.
PubMed 25938056Fong PY, Shih KC, Lam PY, Chan TCY, Jhanji V, Tong L. Role of tear film biomarkers in the diagnosis and management of dry eye disease. Taiwan J Ophthalmol. 2019 Sep 12;9(3):150-159. doi: 10.4103/tjo.tjo_56_19. eCollection 2019 Jul-Sep.
PubMed 31572651Seen S, Tong L. Dry eye disease and oxidative stress. Acta Ophthalmol. 2018 Jun;96(4):e412-e420. doi: 10.1111/aos.13526. Epub 2017 Aug 21.
PubMed 28834388Dogru M, Kojima T, Simsek C, Tsubota K. Potential Role of Oxidative Stress in Ocular Surface Inflammation and Dry Eye Disease. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES163-DES168. doi: 10.1167/iovs.17-23402.
PubMed 30481822Navel V, Sapin V, Henrioux F, Blanchon L, Labbe A, Chiambaretta F, Baudouin C, Dutheil F. Oxidative and antioxidative stress markers in dry eye disease: A systematic review and meta-analysis. Acta Ophthalmol. 2022 Feb;100(1):45-57. doi: 10.1111/aos.14892. Epub 2021 May 2.
PubMed 33938134Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Pacheco-Moises FP, Roman-Pintos LM, Miranda-Diaz AG. The effect of ubiquinone and combined antioxidant therapy on oxidative stress markers in non-proliferative diabetic retinopathy: A phase IIa, randomized, double-blind, and placebo-controlled study. Redox Rep. 2016 Jul;21(4):155-63. doi: 10.1179/1351000215Y.0000000040. Epub 2015 Aug 31.
PubMed 26321469Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Villa-Hernandez D, Hernandez-Godinez PP, Ortiz GG, Pacheco-Moises FP, Cardona-Munoz EG, Miranda-Diaz AG. Oxidants, antioxidants and mitochondrial function in non-proliferative diabetic retinopathy. J Diabetes. 2014 Mar;6(2):167-75. doi: 10.1111/1753-0407.12076. Epub 2013 Aug 21.
PubMed 23875878
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05429229
- Acronym / sponsor ID
- OSRD-20200831-1
- Keywords
- Dry Eye Disease, Oxidative Stress biomarkers, Inflammatory biomarkers, Tear film, Eye drops, Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Adolfo Daniel Rodriguez-CarrizalezUniversity, hospital or other
- Collaborators
- Hospital Civil de Guadalajara
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Clinical trial phase 2 A.
| Arm | Type | Receives |
|---|---|---|
| Q10 coenzyme, vitamin E and cross-linked hyaluronic acid | Experimental | Drug: VisuXL®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. |
| Sodium hyaluronate | Active comparator | Drug: Lagricel PF®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. |
| Sodium hyaluronate and chondroitin sulfate | Active comparator | Drug: Humylub PF®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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisuXL®Also: VisuXL tear dropIt 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. | Drug | Q10 coenzyme, vitamin E and cross-linked hyaluronic acid |
| Lagricel PF®Also: Lagricel preservative freeIt 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. | Drug | Sodium hyaluronate |
| Humylub PF®Also: Humylub preservative freeIt 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. | Drug | Sodium hyaluronate and chondroitin sulfate |
Primary outcome
Change from baseline in levels of tumor necrosis factor alpha (TNF-a) in tear film at 30 days.
Time frame: 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)
Time frame: 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 6 (IL-6)
Time frame: 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 pg/mL.
Change from baseline in levels of interleukin 10 (IL-10)
Time frame: 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)
Changes from baseline in total antioxidant capacity in the tear film at 30 days.
Time frame: 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.
Time frame: 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.
5 secondary outcomes
Change from baseline in the pattern of ocular surface staining with fluorescein sodium according to Oxford Scheme at 30 days.
Time frame: 30 days
Change from baseline in the pattern of ocular surface staining with lissamine green according to Oxford Scheme at 30 days.
Time frame: 30 days
Change from baseline in the tear break-up time (TBUT) in seconds at 30 days.
Time frame: 30 days
Change from baseline in tear film osmolarity at 30 days.
Time frame: 30 days
Change from baseline in tear secretion in mm with Schirmer I test at 30 days.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Background: PubMed 32962301Lopez-Contreras AK, Martinez-Ruiz MG, Olvera-Montano C, Robles-Rivera RR, Arevalo-Simental DE, Castellanos-Gonzalez JA, Hernandez-Chavez A, Huerta-Olvera SG, Cardona-Munoz EG, Rodriguez-Carrizalez AD. Importance of the Use of Oxidative Stress Biomarkers and Inflammatory Profile in Aqueous and Vitreous Humor in Diabetic Retinopathy. Antioxidants (Basel). 2020 Sep 20;9(9):891. doi: 10.3390/antiox9090891.
- Background: PubMed 33182646Pastor-Maldonado CJ, Suarez-Rivero JM, Povea-Cabello S, Alvarez-Cordoba M, Villalon-Garcia I, Munuera-Cabeza M, Suarez-Carrillo A, Talaveron-Rey M, Sanchez-Alcazar JA. Coenzyme Q10: Novel Formulations and Medical Trends. Int J Mol Sci. 2020 Nov 10;21(22):8432. doi: 10.3390/ijms21228432.
- Background: PubMed 28777385Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.
- Background: PubMed 23726741Najafi L, Malek M, Valojerdi AE, Aghili R, Khamseh ME, Fallah AE, Tokhmehchi MR, Behrouz MJ. Dry eye and its correlation to diabetes microvascular complications in people with type 2 diabetes mellitus. J Diabetes Complications. 2013 Sep-Oct;27(5):459-62. doi: 10.1016/j.jdiacomp.2013.04.006. Epub 2013 May 30.
- Background: PubMed 30550113Graue-Hernandez EO, Serna-Ojeda JC, Estrada-Reyes C, Navas A, Arrieta-Camacho J, Jimenez-Corona A. Dry eye symptoms and associated risk factors among adults aged 50 or more years in Central Mexico. Salud Publica Mex. 2018 Sep-Oct;60(5):520-527. doi: 10.21149/9024.
- Background: PubMed 25938056Gao Y, Zhang Y, Ru YS, Wang XW, Yang JZ, Li CH, Wang HX, Li XR, Li B. Ocular surface changes in type II diabetic patients with proliferative diabetic retinopathy. Int J Ophthalmol. 2015 Apr 18;8(2):358-64. doi: 10.3980/j.issn.2222-3959.2015.02.26. eCollection 2015.
- Background: PubMed 31572651Fong PY, Shih KC, Lam PY, Chan TCY, Jhanji V, Tong L. Role of tear film biomarkers in the diagnosis and management of dry eye disease. Taiwan J Ophthalmol. 2019 Sep 12;9(3):150-159. doi: 10.4103/tjo.tjo_56_19. eCollection 2019 Jul-Sep.
- Background: PubMed 28834388Seen S, Tong L. Dry eye disease and oxidative stress. Acta Ophthalmol. 2018 Jun;96(4):e412-e420. doi: 10.1111/aos.13526. Epub 2017 Aug 21.
- Background: PubMed 30481822Dogru M, Kojima T, Simsek C, Tsubota K. Potential Role of Oxidative Stress in Ocular Surface Inflammation and Dry Eye Disease. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES163-DES168. doi: 10.1167/iovs.17-23402.
- Background: PubMed 33938134Navel V, Sapin V, Henrioux F, Blanchon L, Labbe A, Chiambaretta F, Baudouin C, Dutheil F. Oxidative and antioxidative stress markers in dry eye disease: A systematic review and meta-analysis. Acta Ophthalmol. 2022 Feb;100(1):45-57. doi: 10.1111/aos.14892. Epub 2021 May 2.
- Background: PubMed 26321469Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Pacheco-Moises FP, Roman-Pintos LM, Miranda-Diaz AG. The effect of ubiquinone and combined antioxidant therapy on oxidative stress markers in non-proliferative diabetic retinopathy: A phase IIa, randomized, double-blind, and placebo-controlled study. Redox Rep. 2016 Jul;21(4):155-63. doi: 10.1179/1351000215Y.0000000040. Epub 2015 Aug 31.
- Results publication: PubMed 23875878Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Villa-Hernandez D, Hernandez-Godinez PP, Ortiz GG, Pacheco-Moises FP, Cardona-Munoz EG, Miranda-Diaz AG. Oxidants, antioxidants and mitochondrial function in non-proliferative diabetic retinopathy. J Diabetes. 2014 Mar;6(2):167-75. doi: 10.1111/1753-0407.12076. Epub 2013 Aug 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo D Rodriguez-Carrizalez, M.D/PhD study director
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VisuXL®, Lagricel PF® and Humylub PF® in people with Dry Eye Syndromes and Diabetic Retinopathy, run by Adolfo Daniel Rodriguez-Carrizalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adolfo D Rodríguez-Carrizalez, M.D./PhD (+52 33 10585200, leinadkit@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in levels of tumor necrosis factor alpha (TNF-a) in tear film at 30 days. (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05429229, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.