Trial | NCT03946085  Report issue

Title

Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)
Clinical Evaluation of a Micronized, Lipid-based Carotenoid Supplement in Eyes With Retinal Drusen

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    79
The aim of this study is to evaluate the clinical benefits in visual function from dietary supplementation of the Lumega-Z carotenoid liquid-supplement in participants with drusen and at risk of AMD. The effects of Lumega-Z supplementation will be compared to an active comparator, the AREDS2 multivitamin.
Study Started
Jan 19
2018
Primary Completion
Oct 23
2018
Study Completion
Nov 01
2018
Last Update
May 10
2019

Dietary Supplement Lumega-Z

A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.

  • Other names: LMZ

Dietary Supplement AREDS2

A commercially-available multivitamin soft gel formula.

  • Other names: Preservision Age-Related Eye Disease Study 2 (AREDS2)

Lumega-Z group Experimental

Participants assigned the study supplement Lumega-Z.

AREDS2 group Active Comparator

Participants assigned the AREDS2 supplement

Control No Intervention

Participants are determined ocular normal after clinical examination and do not have retinal drusen.

Criteria 

Inclusion Criteria:

- patients with retinal drusen (as determined by clinical fundus photography examination) and dark adaptation recovery time of 6 to 10 minutes.

Exclusion Criteria:

presence of congenital retinal pathologies that may impact data collection
prior history of retinal-detachment or vitreo-retinal surgeries with any complications
best-corrected visual acuity of 20/40 or worse
No Results Posted