Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)

Guardion Health Sciences

Status: Completed

Conditions: Macular Degeneration; Age-related Macular Degeneration; Retinal Drusen

Treatments: Dietary Supplement: AREDS2; Dietary Supplement: Lumega-Z

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03946085

Protocol Number 2

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 3 patient groups

Lumega-Z group

Experimental group

Description:

Participants assigned the study supplement Lumega-Z.

Treatment:

Dietary Supplement: Lumega-Z

AREDS2 group

Active Comparator group

Description:

Participants assigned the AREDS2 supplement

Treatment:

Dietary Supplement: AREDS2

Control

No Intervention group

Description:

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