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.

Study Overview

• Status: Completed
• Conditions: Eye Abnormalities
• Intervention / Treatment: Dietary supplement: Complex product; Dietary supplement: Polyphenol-rich extracts; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80-822
    • Centrum Zdrowia Eter-Med sp. z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complex product; 18 volunteers	Dietary supplement: Complex product; 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
Active Comparator: Polyphenol-rich extracts; 18 volunteers	Dietary supplement: Polyphenol-rich extracts; Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules
Placebo Comparator: Placebo; 18 volunteers	Other: Placebo; Single oral dose - 2 capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEQS (Dry Eye-Related Quality-of-Life) index	Subjective symptom questionnaire assessment	Baseline, 6 weeks
Visual Analogue Scale	Subjective symptom assessment	Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical Coherence Tomography	An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease	Baseline, 6 weeks
Amsler test	Amsler grid usually help detecting defects in central 20 degrees of the visual field	Baseline, 6 weeks
Schirmer test,	Schirmer test quantitatively measures the tear production by the lacrimal gland	Baseline, 6 weeks
Computerized Perimetry	Computerized Perimetry is used to evaluate visual function	Baseline, 6 weeks

Collaborators and Investigators

• Sponsor: AronPharma Sp. z o. o.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ocular diseases; Retinal cells; Blue-light
• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Eye Abnormalities
• Other Study ID Numbers: 05-AP-RET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No