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

Eye Abnormalities Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06004570
• Other study ID #: 05-AP-RET
• Status: Completed
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: AronPharma Sp. z o. o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Abnormalities

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	Centrum Zdrowia Eter-Med sp. z o.o.	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
AronPharma Sp. z o. o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DEQS (Dry Eye-Related Quality-of-Life) index	Subjective symptom questionnaire assessment	Baseline, 6 weeks
Primary	Visual Analogue Scale	Subjective symptom assessment	Baseline, 6 weeks
Secondary	Optical Coherence Tomography	An OCT provides cross sectional images of the retina to enable early detection and treatment of ocular disease	Baseline, 6 weeks
Secondary	Amsler test	Amsler grid usually help detecting defects in central 20 degrees of the visual field	Baseline, 6 weeks
Secondary	Schirmer test,	Schirmer test quantitatively measures the tear production by the lacrimal gland	Baseline, 6 weeks
Secondary	Computerized Perimetry	Computerized Perimetry is used to evaluate visual function	Baseline, 6 weeks