Augmented Macular Pigment-containing Nutraceutical and Central Visual Function
NCT ID: NCT04676126
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2021-05-31
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Lumega-Z
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
Dorzolamide Hcl 2% Oph Soln
Topical carbonic anhydrase inhibitor
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.
Placebo
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study
Interventions
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Lumega-Z
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
Dorzolamide Hcl 2% Oph Soln
Topical carbonic anhydrase inhibitor
Placebo
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Guardion Health Sciences, Inc.
INDUSTRY
University of the Incarnate Word
OTHER
Responsible Party
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Principal Investigators
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Grant T Slagle, DO
Role: PRINCIPAL_INVESTIGATOR
Sponsel Foundation
Locations
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Ophtalmology Clinic of William E Sponsel
San Antonio, Texas, United States
Countries
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References
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Bone RA, Davey PG, Roman BO, Evans DW. Efficacy of Commercially Available Nutritional Supplements: Analysis of Serum Uptake, Macular Pigment Optical Density and Visual Functional Response. Nutrients. 2020 May 6;12(5):1321. doi: 10.3390/nu12051321.
Ma L, Liu R, Du JH, Liu T, Wu SS, Liu XH. Lutein, Zeaxanthin and Meso-zeaxanthin Supplementation Associated with Macular Pigment Optical Density. Nutrients. 2016 Jul 12;8(7):426. doi: 10.3390/nu8070426.
Power R, Coen RF, Beatty S, Mulcahy R, Moran R, Stack J, Howard AN, Nolan JM. Supplemental Retinal Carotenoids Enhance Memory in Healthy Individuals with Low Levels of Macular Pigment in A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Alzheimers Dis. 2018;61(3):947-961. doi: 10.3233/JAD-170713.
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Chew EY, Clemons TE, Agron E, Sperduto RD, Sangiovanni JP, Kurinij N, Davis MD; Age-Related Eye Disease Study Research Group. Long-term effects of vitamins C and E, beta-carotene, and zinc on age-related macular degeneration: AREDS report no. 35. Ophthalmology. 2013 Aug;120(8):1604-11.e4. doi: 10.1016/j.ophtha.2013.01.021. Epub 2013 Apr 10.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20-11-005
Identifier Type: -
Identifier Source: org_study_id
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