Status:

COMPLETED

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

Lead Sponsor:

AronPharma Sp. z o. o.

Conditions:

Eye Abnormalities

Eligibility:

All Genders

25-45 years

Phase:

NA

Brief 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-indu...

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 p...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2023

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT06004570

Start Date

June 15 2023

End Date

September 30 2023

Last Update

November 18 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

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

Gdansk, Poland, 80-822