Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial
Phase: PHASE4
Conditions: Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle
Sponsor: University of the Incarnate Word

Augmented Macular Pigment Supplement and Pericentral Visual Function: A Randomized Controlled 
Trial   
 
NCT #: NCT04676126 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 28 April 2021 
 

Lumega-Z PLUS Randomized Controlled Trial 
 Research Protocol 
 
 
Section 1: Purpose:   
 
 
The purpose of this study is to prospectively analyze changes in macular pigment ocular density 
and dermal carotenoid levels as they relate to perimetry in patients prescribed Lumega-Z, a medical 
food in combination with dorzolamide. 
Section 2: Background and Significance:  
Macular pigments (MP) are a group of fat-soluble carotenoid polyenes that concentrate in the 
human macula and give it its characteristic yellow color.1 They are well studied compounds that 
optimize visual function and protect the macula from high energy visible light, inflammation, and 
oxidative damage.2 
Large historic randomized controlled trials have demonstrated that oral supplementation of 
lutein (L) and zeaxanthin (Z) are associated with macular protection and improvements in contrast 
sensitivity.3–5 Recent investigations have demonstrated that the addition of the third macular pigment, 
meso-zeaxanthin (MZ) increases the bioavailability of both L and Z, and leads to higher MPOD than L and 
Z without MZ.6,7 
Lumega-Z (LM) is a commercially available medical food that includes L, Z, and MZ, among other 
vitamins and minerals. Although this and other similar formulations have been shown to reduce risk of 
ARMD progression, the mechanisms of macular protection portend a benefit in other 
neurodegenerative processes as well. Indeed, high fidelity investigation of the effects of macular 
pigment supplements on memory has demonstrated measurable cognitive improvement.8 
Glaucomatous neuron loss is a complex process with multiple contributing factors, and is not yet 
fully understood.9 Events that likely promote RGC apoptosis10 include disruption of neurotrophic factor 
axonal transport,11 glutamate mediated excitotoxicity,12 oxidative damage,13 and autoimmune 
processes.14,15 The physical and chemical properties of the macular pigments suggest they act to 
attenuate the effects exerted by at least some of these mechanisms. The long polyene backbone of 
these carotenoids, for example, allows them to efficiently and sustainably dissipate energy from reactive 
oxygen species.2,16 
Two of the macular pigments, L and Z, are commonly found in the human diet, and blood levels 
respond directly to changes in dietary or supplemental intake.17–19 Pressure mediated reflection 
spectroscopy has been shown to reliably measure dermal carotenoid levels, which correlate with plasma 
levels. This method can be used to non-invasively monitor carotenoid levels in glaucoma patients.20–22 
Dorzolamide is a topical carbonic anhydrase inhibitor (CAI) commonly used to treat glaucoma by 
inhibiting the production of aqueous humor to reduce intraocular pressure (IOP).23 Incidentally, the 
targeted inhibition of carbonic anhydrase in the ocular circulation may have other effects on retinal and 
visual physiology, including increased retinal blood flow, improved perimetric light sensitivity, contrast 
sensitivity, and perimetric short wavelength sensitivity.24–26 The vasodilation caused by topical CAI’s 
suggest they may enhance delivery of the macular pigments to the retina, and so may have a synergistic 
benefit when paired with LM or other macular pigment-containing oral supplement. 

Briefly, LM has demonstrated favorable effects on two objective measures of visual function: 
macular pigment optical density and contrast sensitivity, and an addition of a topical CAI may enhance 
delivery of the pigments to the macula. Anecdotal experience of the investigators suggests there may be 
an additional benefit in a subset of nutritionally vulnerable glaucoma patients. We therefore 
hypothesize that this subset of patients who experience improvement in visual field function after LM 
supplementation may be nutritionally or physiologically deficient of the macular pigments. This study 
will therefore prospectively examine the effects of LM supplementation in combination with a CAI on 
visual field function, MPOD, and CS in the context of a spectrophotometric analysis of dermal carotenoid 
levels in glaucoma patients compared to untreated controls.  
Section 3: Location, Facility and Equipment to Be Used:  
LOCATION 
311 Camden St, Ste 306, San Antonio, TX 78215  
FACILITY 
The medical office of Dr. William Sponsel 
EQUIPMENT 
1. Slit Lamp (Haag-Streit, Bern, Germany) 
2. Veggie Meter (Longevity Link, Salt Lake City, Utah, USA) 
3. MapcatSF (Guardion Health Sciences, San Diego, California, USA) 
4. Vector Vision (Vector Vision Ocular Health, Greenville, Ohio, USA) 
5. Humphrey Matrix Model 715 FDT Perimeter (Carl Zeiss Meditech, Jena, Germany) 
Section 4: Subjects and Informed Consent:  
All subjects will be recruited from the medical practice of Dr. William E Sponsel. No advertising 
shall be employed. Eligible patients will be verbally informed of the study. If they express interest a 
detailed description of the study will be presented, including the written informed consent (attached) If 
they elect to participate, written informed consent will be obtained prior to any data collection. Consent 
documents will be available in both English and Spanish. Translation into Spanish will be performed by 
investigators fluent in the language. All study records will be anonymized and maintained on an 
encrypted and password protected computer under the control of the PI. Only aggregated mean results 
will be published in the scientific press. 
PARTICIPANTS 
This prospective double-masked, randomized, placebo-controlled study will consist of 30 
subjects age >18 with the diagnosis of Glaucoma (ICD-10: H40. *). Only patients under the care of the 
investigating surgeon (WES) will be considered. Subjects will be identified at the time they are deemed 
to be candidates for Lumega-Z supplementation (adequate IOP control with RNFL or visual field 
glaucomatous progression).  After verifying no history of AREDS formula oral supplement use, patients 
will be approached by the co-investigator (GTS) in the principal investigator’s ophthalmology clinic and 
asked if they are interested in participating in this study. An Excel (Microsoft, Redmond, WA) 
spreadsheet with deidentified data will be kept in clinic on-site on a password-protected computer in 

order to store and analyze data. GTS is a full-time employee at the investigating practice and has 
HIPPAA-compliant access to patients and patient records independent of this study. 
INFORMED CONSENT 
Before study participation, participants will have a consultation with a representative 
investigator at the clinical practice of WES (311 Camden St Ste. 306, San Antonio, TX, 78215) in which 
they will be informed of the risks, benefits, and alternatives of participating in the study. They will be 
assured that their decision to participate or not will have no bearing on their personal or medical 
treatment by the investigators. Subjects will be given a printed copy of their signed informed consent. 
Completed informed consent forms will be scanned and stored on their patient profile of a password 
protected and encrypted electronic medical record. After they are scanned onto the electronic medical 
record, the hard copies will be shredded. Participants will be given a copy of the signed informed 
consent forms. 
Inclusion Criteria 
-Age ≥ 18 years 
-Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 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 
visual field)  
-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 
-Patient reports taking LM supplement ≤ 2 times per week or cannot tolerate oral supplement intake 
-Patient loses IOP control and 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 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 
-Sulfa Allergy 
 
 
Section 5: Subject Compensation:  
Subjects will be compensated with gift cards according to the following schedule: 
Visit 1: $25 
Visit 2: $25 
Visit 3: $25 
Visit 4: $100 
Funding will be provided by the study sponsor: Guardion Health Sciences, Inc. 
Section 6: Duration:  
Patient recruitment, data collection, data analysis, and abstract/manuscript writing will take 6-
12 months.  
Section 7: Research Design (Description of the Experiment, Data Collection and Analysis):  
1. Study Design 
This is a prospective double-masked, randomized controlled study which compares pre-Lumega-Z 
supplementation MPOD, CS, dermal carotenoid levels, and visual field status to post-supplement 
measurements of the same. Participants will be randomized to twelve weeks of LM + dorzolamide or 
twelve weeks of placebo. All packaging of LM and dorzolamide and their placebos will be identical and 
distributed by a third party. Both subjects and the investigators examining patients will be masked to 
placebo and experimental groups. 
2. Supplement and CAI Dosing and Distribution 

LumegaZ is a commercially available medical food (see ingredient table) which is consumed daily in a 
1.5 Tbsp (0.75 FL OZ) dose. Subjects will be offered a 3-month supply (or placebo) for the duration of the 
study. Dosing instructions are included on the packaging. 
The CAI which will be used in this study is Dorzolamide 2% ophthalmic solution used as follows: one 
drop in the affected (or both) eye three times per day. Dosing instructions are included on the 
packaging. 
LumegaZ and CAI (or placebo) will be distributed upon recruitment in a single package which is 
identical to the standard LM supplement. Lot number will be recorded and used to determine whether 
subjects were in the placebo or supplement group after data gathering is complete. 
Ingredient 
Amount  Ingredient 
Amount 
Vitamin C 
500mg  Copper 
2 mg 
Vitamin D3 
2000 IU  Manganese 
2 mg 
Vitamin E 
200 IU  Chromium 
120 mcg 
Thiamin 
1.5mg  Molybdenum 
75 mcg 
Riboflavin 
1.7mg  N-acetyl-cysteine 
500 mg 
Vitamin B3 
20 mg  Acetyl-L-Carnitine 
500 mg 
Vitamin B6 
10 mg  L-Taurine 
500 mg 
Folate 
800mcg  Quercetin 
100 mg 
Vitamin B12 
1000 mcg  CoQ10 
50 mg 
Biotin 
100 mcg  Lutein 
15 mg 
Panothenoic Acid 
10 mg  Meso-zeaxanthin 
3 mg 
Calcium 
250 mg  Astaxanthin 
1000 mcg 
Magnesium 
100 mg  Lycopene 
500 mcg 
Zinc 
25 mg  Alpha-lipoic acid 
200mg 
Selenium 
70 mcg  
  
3. Randomization 
After recruitment, subjects will be registered as a study participant and randomized by computer 
generated randomization table generated prior to subject recruitment to be in the placebo or 
intervention group by a Guardion Health Sciences representative without access to patient data. The 
Guardion representative will receive the subject name and delivery address only, which is the same 
information they receive for every patient prescribed this medical food.   

The clinically active investigators and subjects will be masked to group assignment for the duration 
of the study. The placebo will be distributed directly to participants’’ homes in packaging identical to the 
standard LM product in a single shipment.  
Dermal carotenoid measurement will be randomized by computer generated random number table 
to the right or left index finger of each subject at the initial visit. The same finger will be used at every 
follow-up visit. 
MPOD is measured in one eye only, as there is very high correlation in values measured between 
eyes.27 At the initial visit, the measured eye will be randomized by computer generated random number 
table. The same eye will be measured at every follow up visit. 
4. Data Collection for dermal carotenoids, MPOD, and CS 
All participants will have dermal carotenoid levels, MPOD, and CS measured at every visit up to 3 
months after starting LM. The baseline measurements will be taken on the day of enrollment, then 
follow-up measurements will be taken 1 month, 2 months, and 3 months after initiation of topical 
dorzolamide + LM oral supplementation. 
a. Dermal Carotenoid Levels with Veggie Meter® 
After finger randomization, the Veggie Meter® will be light- and dark- calibrated before every 
measurement. Smoking status, age, height, weight, handedness, and finger used will be documented at 
the time of data acquisition. Participants will be seated and insert the randomized index finger into the 
device, placed on a table at the level of the patients’ heart. After a short wait of 3-10 seconds to allow 
for finger-tip compression by the device, optical data acquisition will begin (no blood sample is 
collected). After the ~5 seconds required to acquire data, the finger will be removed for ≥ 10 seconds to 
allow for recirculation of the tested finger. The measurement will be repeated 2 more times (for a total 
of 3 measurements per visit) and a carotenoid score will be reported and recorded as the average of the 
3 values. 
b. Macular Pigment Optical Density with Heterochromatic Flicker Photometry 
This data will be acquired as follows: After eye randomization the patient will be fitted into the 
device. They will be instructed to look at the center of a flashing circle and adjust the device to correct 
for their refractive error. A human operator will follow an independently developed algorithm 
(attached) to determine MPOD ± standard deviation, which will be calculated by the Mapcat device and 
recorded at each visit. 
 
c. Contrast Sensitivity with VectorVision 
Participants will be asked to identify the location of a sine-wave gradient in a series of images by 
selecting the circle with the gradient as top, bottom, or neither. This will be repeated for all 4 different 
spatial frequencies and plotted on a contrast sensitivity curve. 
5. Perimetry 
All participants will have a baseline Frequency Doubling Technology (FDT) 10-2 taken no more 
than 1 month before starting LM supplementation. Follow-up FDT 10-2 testing will also be completed at 
3 months after LM initiation. 

6. Power Analysis 
The primary outcome measure in this study is dermal carotenoid levels, so power analysis with 
mean baseline score reported in the population is 335 ± 13.7, and conservative expected increase in 
carotenoid score to 360 with an alpha of 0.05 and a beta of 0.90 given a calculated n of 12 subjects. We 
will therefore recruit 30 subjects to participate in this study – 15 intervention and 15 controls. 
 
 
7. Data Analysis 
Pre-supplement dermal carotenoid scores, FDT 10-2 MD and pericentral sensitivity, MPOD, and 
CS parameters will be compared within subjects at the 1-month (except perimetry), 2-month (except 
perimetry), and 3-month time points using a two-way Repeated-measures ANOVA with post-hoc t-
testing for evaluation of significant differences. 
All investigators will contribute to data analysis. 
Section 8: Risk Analysis:  
LM is a medical food with well-studied ingredients established to be safe, and are effective at 
preventing progression of mild-moderate age-related macular degeneration. A 10-year follow-up on the 
AREDS study cohort found zero MP-related adverse events in 4757 participants.28 
Dorzolamide is a very common topical antiglaucoma medication. It is reasonably well tolerated, 
but adverse reactions may occur. These include ocular allergy, burning, stinging, and bitter taste. 
Burning and stinging may occur in as many as 40% of patients but this does not typically warrant 
discontinuation of the drug.29 Preservative free formulations of dorzolamide can be used in cases of 
ocular allergy, and patients who cannot otherwise tolerate the stinging/burning will be excluded from 
the study. 
MPOD tests involve looking at a flickering light. It is conceivable that in a predisposed individual, 
focusing on such a stimulus may trigger a seizure.30 There are no reports in the literature of a Mapcat 
device triggering an epileptic seizure. As an added precaution, patients who are recruited for the study 
will be screened for a history of photosensitive seizures. 
Dermal carotenoid measurement involves the application of moderate pressure on the index 
finger. This may cause pain in vulnerable patients, for example those with a history of arthritis or gout 
affecting the distal interphalangeal joint of the second digit. A physical exam by an investigating 
physician will identify patients who may be vulnerable to such pain and they will be informed that they 
can be removed from the study if they cannot tolerate the finger pressure. 
Contrast sensitivity and involves identifying which of a set of circles has stripes. There are no 
known risks associated with conducting this test. 
It is feasible that patients in the placebo group will be subject to increased risk of glaucomatous 
progression because they will not start on the topical carbonic anhydrase inhibitor, which has been 
shown to reduce IOP. Only patients with adequately controlled IOP will be included in the study, so 
topical CAI would otherwise not be indicated for their treatment regimen. Therefore, placebo patients 

will still be receiving the standard of care for their glaucoma. Any patients with unexpected findings 
(such as elevated IOP) at any of the study visits requiring additional intervention will receive it.  
COVID-19 Statement 
The investigators acknowledge the current COVID-19 pandemic and associated risks. While the 
majority of COVID-19 infections are asymptomatic or mild severity, there is a risk of severe respiratory 
illness which can result in hospitalization, admission to the intensive care unit, intubation, chronic 
respiratory, cardiac, or neurologic sequalae, and death (risk varies widely and increases with age, 
although a global estimate is ~3%).31 
Robust COVID-19 risk mitigation protocols are already in place at the investigating practice, 
which include the use of symptom and temperature screening, social distancing, intensive room and 
device cleaning with germicidal substances, thorough personal hygiene, use of personal protective 
equipment (PPE), and contact tracing and testing protocols to monitor exposed individuals. PPE includes 
N95 or equivalent facemasks, isolation gowns, gloves, eye protection, and plexiglass slit lamp face 
shields. Patients are also required to wear face masks at all times while in the clinic and are required to 
practice hand hygiene upon arrival. No patients with known or suspected COVID-19 infection are 
permitted in the clinic. These protocols are informed by, and exceed the requirements set forth by the 
US Centers for Disease Control.32 
Section 9: Confidentiality:  
All records shall be anonymized and maintained on a password-protected encrypted computer 
under the control of the PI. Only aggregated, mean results will be published in the scientific press. 
 
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