Back to resultsEffects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
Primary Purpose
Eye Abnormalities
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Complex product
Polyphenol-rich extracts
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Eye Abnormalities focused on measuring Retinal cells, Ocular diseases, Blue-light
Eligibility Criteria
Inclusion Criteria: Women and men, 25-45 years old. Signed informed consent. Volunteers who do not use glasses or contact lenses. Volunteers exposed to blue light for at least 6 - 8 hours a day. Exclusion Criteria: Intake of supplements containing plant extracts, polyphenols or anthocyanins. Participation in another clinical trial. Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study. Women who are pregnant, planning to become pregnant during the study, or breastfeeding. Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids). Current use of eye drops in the treatment of ocular diseases. Ocular diseases.
Sites / Locations
- Centrum Zdrowia Eter-Med sp. z o.o.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Complex product
Polyphenol-rich extracts
Placebo
Arm Description
18 volunteers
18 volunteers
18 volunteers
Outcomes
Primary Outcome Measures
DEQS (Dry Eye-Related Quality-of-Life) index
Subjective symptom questionnaire assessment
Visual Analogue Scale
Subjective symptom assessment
Secondary Outcome Measures
Optical Coherence Tomography
An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease
Amsler test
Amsler grid usually help detecting defects in central 20 degrees of the visual field
Schirmer test,
Schirmer test quantitatively measures the tear production by the lacrimal gland
Computerized Perimetry
Computerized Perimetry is used to evaluate visual function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06004570
Brief Title
Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
Official Title
Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AronPharma Sp. z o. o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to confirm that daily supplementation with a product containing a standardized combination of polyphenol-rich extracts has a protective effect against potential blue-light-induced damage to retinal cells.
Detailed Description
Randomized, double-blind, parallel study conducted under medical supervision on a group of 54 volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life Questionnaire. The studied parameters will be measured before and after supplementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Abnormalities
Keywords
Retinal cells, Ocular diseases, Blue-light
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Complex product
Arm Type
Experimental
Arm Description
18 volunteers
Arm Title
Polyphenol-rich extracts
Arm Type
Active Comparator
Arm Description
18 volunteers
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
18 volunteers
Intervention Type
Dietary Supplement
Intervention Name(s)
Complex product
Intervention Description
Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica, rutin, vitamin B6, vitamin B12, folic acid Single oral dose - 2 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyphenol-rich extracts
Intervention Description
Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single oral dose - 2 capsules
Primary Outcome Measure Information:
Title
DEQS (Dry Eye-Related Quality-of-Life) index
Description
Subjective symptom questionnaire assessment
Time Frame
Baseline, 6 weeks
Title
Visual Analogue Scale
Description
Subjective symptom assessment
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Optical Coherence Tomography
Description
An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease
Time Frame
Baseline, 6 weeks
Title
Amsler test
Description
Amsler grid usually help detecting defects in central 20 degrees of the visual field
Time Frame
Baseline, 6 weeks
Title
Schirmer test,
Description
Schirmer test quantitatively measures the tear production by the lacrimal gland
Time Frame
Baseline, 6 weeks
Title
Computerized Perimetry
Description
Computerized Perimetry is used to evaluate visual function
Time Frame
Baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women and men, 25-45 years old.
Signed informed consent.
Volunteers who do not use glasses or contact lenses.
Volunteers exposed to blue light for at least 6 - 8 hours a day.
Exclusion Criteria:
Intake of supplements containing plant extracts, polyphenols or anthocyanins.
Participation in another clinical trial.
Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids).
Current use of eye drops in the treatment of ocular diseases.
Ocular diseases.
Facility Information:
Facility Name
Centrum Zdrowia Eter-Med sp. z o.o.
City
Gdańsk
ZIP/Postal Code
80-822
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Khaidakov, PhD
Phone
798 210 651
Ext
+48
Email
barbara.khaidakov@aronpharma.pl
First Name & Middle Initial & Last Name & Degree
Janusz Wietecha
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
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