NCT06004570

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-induced damage to retinal cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

August 7, 2023

Last Update Submit

November 15, 2023

Conditions

Eye Abnormalities

Keywords

Retinal cellsOcular diseasesBlue-light

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Optical Coherence Tomography

    Baseline, 6 weeks

  • Amsler test

    Baseline, 6 weeks

  • Schirmer test,

    Baseline, 6 weeks

  • Computerized Perimetry

    Baseline, 6 weeks

Study Arms (3)

Complex product

EXPERIMENTAL

18 volunteers

Dietary Supplement: Complex product

Polyphenol-rich extracts

ACTIVE COMPARATOR

18 volunteers

Dietary Supplement: Polyphenol-rich extracts

Placebo

PLACEBO COMPARATOR

18 volunteers

Other: Placebo

Interventions

Complex productDIETARY_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

Complex product
Polyphenol-rich extractsDIETARY_SUPPLEMENT

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

Polyphenol-rich extracts
PlaceboOTHER

Single oral dose - 2 capsules

Placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gdansk, 80-822, Poland

Location

MeSH Terms

Conditions

Eye Abnormalities

Condition Hierarchy (Ancestors)

Eye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 22, 2023

Study Start

June 15, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)