NCT04741763

Brief Summary

Vision at twilight and night is more difficult and dangerous for the entire population, even more so for the elderly and especially for the elderly with degenerative disease. Multiple worldwide laboratories have demonstrated the ability to raise macular pigment optical density with dietary carotenoids. This proposal further evaluates the relationship between macular re- pigmentation and vision under stressed conditions simulating twilight and night driving.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

February 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

January 13, 2021

Last Update Submit

February 3, 2021

Conditions

Macular Degeneration

Keywords

Macular Disease

Outcome Measures

Primary Outcomes (1)

  • MPOD

    1 degree macular pigment optic density

    24 weeks

Secondary Outcomes (3)

  • Vimetrics Central Vision Analyzer (CVA)

    24 weeks

  • LuxIQ- preferred luminance

    24 weeks

  • Useful Field of Vision (UFOV) Brain HQ

    24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin Placebo: Experimental is 1:2

Dietary Supplement: EyePromise Visual Edge

Active

EXPERIMENTAL

Eye Promise Visual Edge containing 8 mg zeaxanthin \& 4 mg lutein Placebo: Experimental is 1:2

Dietary Supplement: EyePromise Visual Edge

Interventions

EyePromise Visual EdgeDIETARY_SUPPLEMENT

A dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients

ActivePlacebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No significant supplementary carotenoids within last 10 weeks. Without significant media opacity, cataract or congenital / acquired retinal disease other than atrophic AMD or diabetic retinopathy. Minimum 20/25 to enroll.

You may not qualify if:

  • Unwilling or medically / psychiatrically unable to take part in a 6 month study.
  • Recent ophthalmologic surgery or treatment.
  • Tricare, Retirees \& Enlisted Navy Personnel excluded. Already taking an OTC product to improve their night vision (containing carotenoids, polyphenols like bilberry).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Captain James A. Lovell Federal Health Care Center (FHCC)

North Chicago, Illinois, 60064, United States

Location

Davis EyeCare

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Steven Novil, PhD, ND

    Optometry Research Lab manager, Optometry Clinic- Captain James A Lovell FHCC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Research coded bottles with code held by the sponsor. Gel caps will be supplied in a single 180 count bottle. 1 gel cap per day will be taken with a meal.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Capsule type that results in null or increased MPOD (macular pigment optical density in du -density units) - either Maltodextrin Placebo or OTC commercial "Night Vision Formulation" consisting of 21 mg carotenoid capsule (14 mg zeaxanthin and 7mg lutein) supplied by www.zeavision.com (Chesterfield, MO) in research coded bottles with code held by the company. Gel caps will be supplied in a single 180 count bottle. 1 gel cap per day will be taken with a meal. Subjects will be called by telephone to improve compliance. Supplement compliance will ultimately be gauged by the number of tablets returned.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
co-investigator

Study Record Dates

First Submitted

January 13, 2021

First Posted

February 5, 2021

Study Start

February 13, 2018

Primary Completion

August 20, 2019

Study Completion

August 20, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Locations

US(2)