Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

NCT04676126 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20-11-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Glaucoma Eye; Glaucoma, Open-Angle

Keywords

Lumega-Z; Macular Pigment; Macular Pigment Optical Density; Contrast Sensitivity; Humphrey Visual Field 10-2; Dermal Carotenoid; MapcatSF; Veggie Meter; Vector Vision; Pericentral Visual Field

Outcome Measures

Primary Outcomes (1)

• Pericentral Visual Function

  Mean deviation and pattern standard deviation of 10-2 Humphrey visual field

  3 Months

Secondary Outcomes (3)

• Macular Pigment Optical Density

  Monthly for 3 months

• Dermal Carotenoid Levels

  Monthly for 3 months

• Contrast Sensitivity

  Monthly for 3 months

Study Arms (2)

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; Drug: Dorzolamide Hcl 2% Oph Soln

Placebo

PLACEBO COMPARATOR

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

Interventions

Lumega-Z DIETARY_SUPPLEMENT

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

Experimental

Dorzolamide Hcl 2% Oph Soln DRUG

Topical carbonic anhydrase inhibitor

Also known as: Azopt

Experimental

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Incarnate Word: lead
• Guardion Health Sciences, Inc.: collaborator

Study Sites (1)

Ophtalmology Clinic of William E Sponsel

San Antonio, Texas, 78215, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Interventions

dorzolamide; brinzolamide

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Grant T Slagle, DO

  Sponsel Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 19, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)