NCT04775654

Brief Summary

The purpose of this study is to evaluate the potential for supplementation with black currant to support eye health among otherwise healthy adult women who spend 6+ hours per day using digital screens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

February 25, 2021

Last Update Submit

January 20, 2022

Conditions

Eye StrainEye Fatigue

Keywords

black currantblackcurrantRibes nigrumdigital eye fatigueeye healthcomputer vision syndromedietary supplement

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in ocular discomfort on day 70.

    The Ocular Discomfort scale is a validated self reported instrument assessing ocular discomfort symptoms. The scale contains 6 domains with a combination of likert scale (ranging from 1-7) and dichotomous (yes/no) questions. Higher scores indicate greater visual fatigue.

    Baseline and day 70

  • Change from baseline in visual fatigue on day 70.

    The Visual Fatigue scale is a validated self reported instrument assessing visual fatigue symptoms. It is a 6-question scale which asks about immediate symptoms (such as dry eyes). Participants rank their symptoms on a likert scale scored from 1-7, with higher scores indicating more severe symptoms.

    Baseline and day 70

  • Change from baseline in computer vision symptoms on day 70.

    The Computer Vision Symptom scale is a validated self reported instrument assessing computer vision symptoms. The scale measures 17 symptom domains, with scores ranging from 1-4 to 1-7. On each domain, higher scores indicate greater severity.

    Baseline and day 70

  • Change from baseline in symptoms of computer vision syndrome on day 70.

    The Computer Vision Syndrome Questionnaire is a validated self reported instrument assessing computer vision symptoms. The scale measures the presence or absence of 16 symptoms producing scores from 0-16. Higher scores indicate more symptoms.

    Baseline and day 70

Study Arms (2)

Supplement

EXPERIMENTAL

Participants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days.

Dietary Supplement: Blackcurrant

Placebo

PLACEBO COMPARATOR

Participants consume 2 capsules of microcrystalline cellulose for 70 days.

Other: Placebo

Interventions

BlackcurrantDIETARY_SUPPLEMENT

Two capsules containing 455mg of CurrantCraft 11% black currant extract.

Supplement
PlaceboOTHER

Two capsules containing an inert material.

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Age 30-60
  • Lives in the United States
  • Employed full time in an online work environment OR enrolled full time in an online learning environment (average of 6+ hours per day)
  • Ability to understand study instructions
  • Ability to provide informed consent
  • Residence within 100 miles of the study center

You may not qualify if:

  • Low blood pressure
  • Uncontrolled hypertension (i.e. systolic/diastolic blood pressure \> 140/90)
  • Uncontrolled diabetes (i.e. fasting blood glucose \>180mg/dl)
  • Any blood clotting disorder
  • Ocular disease
  • Best corrected visual acuity \<20/30
  • Cataracts
  • Renal disease
  • Active hepatitis or cirrhosis
  • Acute or chronic infectious disease
  • Pregnant
  • Breastfeeding
  • Currently trying to conceive
  • Surgical or other invasive procedure planned within the intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Jessie R Hawkins, PhD

    Franklin Health Research & Education Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and the individuals providing informed consent are masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)