NCT04676126

Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of the Incarnate Word · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.

Detailed description

This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.

Conditions

• Glaucoma
• Glaucoma Eye
• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lumega-Z	Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
DRUG	Dorzolamide Hcl 2% Oph Soln	Topical carbonic anhydrase inhibitor
OTHER	Placebo	Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2020-12-19
• Last updated: 2022-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study