Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

Sponsor

University of the Incarnate Word (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04676126

Collaborator

Guardion Health Sciences, Inc. (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Glaucoma Eye Glaucoma, Open-Angle	Dietary Supplement: Lumega-Z Drug: Dorzolamide Hcl 2% Oph Soln Other: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a prospective double-masked, randomized controlled study which compares pre- supplementation macular pigment optical density, contrast sensitivity, dermal carotenoid levels, and visual field status to post-supplement measurements of the same.This is a prospective double-masked, randomized controlled study which compares pre- supplementation macular pigment optical density, contrast sensitivity, dermal carotenoid levels, and visual field status to post-supplement measurements of the same.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

A remotely located Guardion Health Sciences designee will utilize a computer-generated random number table to assign patients to placebo or experimental group. Subjects will have the supplement/placebo delivered to their homes in identical (except lot number) packaging.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Subjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months.	Dietary Supplement: Lumega-Z Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin Drug: Dorzolamide Hcl 2% Oph Soln Topical carbonic anhydrase inhibitor Other Names: Azopt
Placebo Comparator: Placebo Subjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months.	Other: Placebo Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study

Arm

Intervention/Treatment

Experimental: Experimental

Subjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months.

Dietary Supplement: Lumega-Z

Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin

Drug: Dorzolamide Hcl 2% Oph Soln

Topical carbonic anhydrase inhibitor

Other Names:

Azopt

Placebo Comparator: Placebo

Subjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months.

Other: Placebo

Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study

Outcome Measures

Primary Outcome Measures

Pericentral Visual Function [3 Months]
Mean deviation and pattern standard deviation of 10-2 Humphrey visual field

Secondary Outcome Measures

Macular Pigment Optical Density [Monthly for 3 months]
Macular Pigment Optical Density measured by Mapcat SF
Dermal Carotenoid Levels [Monthly for 3 months]
Measured by Veggie Meter
Contrast Sensitivity [Monthly for 3 months]
Measured by Vector Vision CSV-2000

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00)
Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months
Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF)
Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters

Exclusion Criteria:

BCVA worse than 20/200
Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures
Loss of IOP control requires surgical intervention
Patient already taking AREDS formula oral supplement
Patient taking medication or dietary supplements that may interact with LM ingredients
History of photosensitive epilepsy
History of penetrating ocular trauma or vitrectomy
History of ocular or orbital radiation therapy or is currently receiving chemotherapy
Women who are nursing, pregnant, or are planning pregnancy
Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid.
Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment.
Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery < 3 months before enrollment
Native lens opacity ≥ grade 3 on ARLNS standard photograph
Blue light filter intraocular lens