Clinical trial NCT04676126: Augmented Macular Pigment-containing Nutraceutical and Central Visual Function
Official title: Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
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
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
Collaborators: name: Guardion Health Sciences, Inc.
First posted: 2020-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pericentral Visual Function
timeFrame: 3 Months
Secondary outcomes:
measure: Macular Pigment Optical Density
timeFrame: Monthly for 3 months
measure: Dermal Carotenoid Levels
timeFrame: Monthly for 3 months
measure: Contrast Sensitivity
timeFrame: Monthly for 3 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Ophtalmology Clinic of William E Sponsel
state: Texas
Study officials:
affiliation: Sponsel Foundation
name: Grant T Slagle, DO
role: PRINCIPAL_INVESTIGATOR
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