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Completed

NCT Number: NCT06004570

Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases

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.

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Key information

Conditions

Eye Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centrum Zdrowia Eter-Med sp. z o.o.

Gdansk, 80-822, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complex product

Dietary 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 extracts

Dietary Supplement

Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules

Placebo

Other

Single oral dose - 2 capsules

Primary outcomes

  1. DEQS (Dry Eye-Related Quality-of-Life) index

    Time frame: Baseline, 6 weeks

    Subjective symptom questionnaire assessment

  2. Visual Analogue Scale

    Time frame: Baseline, 6 weeks

    Subjective symptom assessment

Secondary outcomes

  1. Optical Coherence Tomography

    Time frame: Baseline, 6 weeks

    An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease

  2. Amsler test

    Time frame: Baseline, 6 weeks

    Amsler grid usually help detecting defects in central 20 degrees of the visual field

  3. Schirmer test,

    Time frame: Baseline, 6 weeks

    Schirmer test quantitatively measures the tear production by the lacrimal gland

  4. Computerized Perimetry

    Time frame: Baseline, 6 weeks

    Computerized Perimetry is used to evaluate visual function

Sponsors and collaborators

Lead sponsor

AronPharma Sp. z o. o.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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