Eye AbnormalitiesNCT06004570
Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
A study testing Complex product and Polyphenol-rich extracts in people with Eye Abnormalities, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Abnormalities
- What is being tested?
- Complex product and Polyphenol-rich extracts
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jun 2023to 30 Sep 2023
- Phase
- Interventional
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Eye Abnormalities
- Being tested
- Complex product, Polyphenol-rich extracts, Placebo
- Keywords
- Retinal cells, Ocular diseases, Blue-light
- Medical subject headings
- Eye Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex productDietary supplement
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
Polyphenol-rich extractsDietary supplement
Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules
PlaceboOther
Single oral dose - 2 capsules
| Study group | Role | What they receive |
|---|---|---|
| Complex product | Experimental | 18 volunteers Receives: Dietary Supplement: Complex product |
| Polyphenol-rich extracts | Active comparator | 18 volunteers Receives: Dietary Supplement: Polyphenol-rich extracts |
| Placebo | Placebo comparator | 18 volunteers Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEQS (Dry Eye-Related Quality-of-Life) index
Subjective symptom questionnaire assessment
Measured: Baseline, 6 weeks
Visual Analogue Scale
Subjective symptom assessment
Measured: Baseline, 6 weeks
Secondary outcomes (4)
Optical Coherence Tomography
An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease
Measured: Baseline, 6 weeks
Amsler test
Amsler grid usually help detecting defects in central 20 degrees of the visual field
Measured: Baseline, 6 weeks
Schirmer test,
Schirmer test quantitatively measures the tear production by the lacrimal gland
Measured: Baseline, 6 weeks
Computerized Perimetry
Computerized Perimetry is used to evaluate visual function
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start15 Jun 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye AbnormalitiesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004570
- Sponsor's protocol ID
- 05-AP-RET
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06004570
- Acronym / sponsor ID
- 05-AP-RET
- Conditions
- Eye Abnormalities
- Keywords
- Retinal cells, Ocular diseases, Blue-light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Aug 2023 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Complex product | Experimental | Dietary Supplement: Complex product18 volunteers |
| Polyphenol-rich extracts | Active comparator | Dietary Supplement: Polyphenol-rich extracts18 volunteers |
| Placebo | Placebo comparator | Other: Placebo18 volunteers |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| Complex productExtracts 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 | Dietary supplement | Complex product |
| Polyphenol-rich extractsExtracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules | Dietary supplement | Polyphenol-rich extracts |
| PlaceboSingle oral dose - 2 capsules | Other | Placebo |
Primary outcome
DEQS (Dry Eye-Related Quality-of-Life) index
Time frame: Baseline, 6 weeks
Subjective symptom questionnaire assessment
Visual Analogue Scale
Time frame: Baseline, 6 weeks
Subjective symptom assessment
4 secondary outcomes
Optical Coherence Tomography
Time frame: Baseline, 6 weeks
Amsler test
Time frame: Baseline, 6 weeks
Schirmer test,
Time frame: Baseline, 6 weeks
Computerized Perimetry
Time frame: Baseline, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Eye Abnormalities
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex product and Polyphenol-rich extracts in people with Eye Abnormalities, run by AronPharma Sp. z o. o. at 1 site in Poland.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 18 Nov 2023. 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 Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEQS (Dry Eye-Related Quality-of-Life) index (time frame: Baseline, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.