An interventional study of Complex product and Polyphenol-rich extracts in Eye Abnormalities, sponsored by AronPharma Sp. z o. o.. Completed at 1 site in Poland. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by AronPharma Sp. z o. o. · Not applicable, Interventional, and Supportive care
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.
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.
28 studies on the registry are indexed under Eye Abnormalities; 3 are open to participants now.
This study's enrollment of 22 is close to the median of 22 across 13 interventional studies indexed under Eye Abnormalities.
Browse Eye Abnormalities studies →AronPharma Sp. z o. o. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
18 volunteers
Dietary Supplement: Complex product
18 volunteers
Dietary Supplement: Polyphenol-rich extracts
18 volunteers
Other: Placebo
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
Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules
Single oral dose - 2 capsules
DEQS (Dry Eye-Related Quality-of-Life) index
Subjective symptom questionnaire assessment
Time frame: Baseline, 6 weeks
Visual Analogue Scale
Subjective symptom assessment
Time frame: Baseline, 6 weeks
Optical Coherence Tomography
An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease
Time frame: Baseline, 6 weeks
Amsler test
Amsler grid usually help detecting defects in central 20 degrees of the visual field
Time frame: Baseline, 6 weeks
Schirmer test,
Schirmer test quantitatively measures the tear production by the lacrimal gland
Time frame: Baseline, 6 weeks
Computerized Perimetry
Computerized Perimetry is used to evaluate visual function
Time frame: Baseline, 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Sep 2023, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AronPharma Sp. z o. o.