NCT06004570

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: AronPharma Sp. z o. o. · Industry
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Eye Abnormalities

Interventions

Type	Name	Description
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
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
OTHER	Placebo	Single oral dose - 2 capsules

Timeline

• Start date: 2023-06-15
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-08-22
• Last updated: 2023-11-18

Locations

1 site across 1 country: Poland