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Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

NCT04676126 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-10-04

No results posted yet for this study

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.

Conditions

  • Glaucoma
  • Glaucoma Eye
  • Glaucoma, Open-Angle

Interventions

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

Sponsors & Collaborators

  • Guardion Health Sciences, Inc.

    collaborator INDUSTRY

  • University of the Incarnate Word

    lead OTHER

Principal Investigators

  • Grant T Slagle, DO · Sponsel Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676126 on ClinicalTrials.gov