Clinical Evaluation of a Micronized, Lipid-based Carotenoid Supplement in Eyes With Retinal Drusen
Phase: NA
Conditions: Retinal Drusen, Age-related Macular Degeneration, Macular Degeneration
Sponsor: Guardion Health Sciences, Inc.

 
 
 
 
18 January 2018 
 
Thomas T. Henderson, MD 
Attn:  Valerie Gatavaski, COA 
Eye Clinic of Austin 
3410 Far West Boulevard, Suite 140 
Austin, TX 78731 
 
Re:   GUARDiON Health Sciences, Inc., Protocol number 1   
 
Dear Dr. Henderson: 
 
The Protocol Version 2 dated 27 DEC 2017, and revisions to the Informed Consent Document (ICD) 
were approved using the expedited review procedure on 17 January 2018, as reflected on the attached 
document.   
 
Due to the nature of the modifications, the reviewer has determined that reconsenting is required. 
Investigators must consider enrollment at their site as of the approval date listed and ensure any 
participants enrolled are reconsented at the next study visit.  
 
If you have questions, or if we can provide further assistance, please contact our office at (512) 380-1244 
or at salus@salusirb.com.   
 
Sincerely, 
 
Trina Anderson, CCRP, CIP 
Quality Systems Manager 
 
 
 
 

 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB:  17 JANUARY 2018 
 
 
 
 
 
 
 
 
 
AN AGREEMENT TO BE IN A RESEARCH STUDY 
INFORMED CONSENT DOCUMENT 
 
Sponsor: 
 
GUARDiON HEALTH SCIENCES, Inc. 
City and State: 
 
San Diego, California  
 
Protocol Number and Title: 
1, Version 2: Controlled Study of the Effect of 
a      Medical    
Food Containing All Three 
Carotenoids and  
Essential 
Cofactors 
Compared to AREDS2 on  Early 
Macular 
Degeneration 
 
Study Doctor: 
 
Thomas T. Henderson, MD 
 
Address of Study Site: 
 
Eye Clinic of Austin 
 
 
 
 
3410 Far West Blvd, Suite 140 
 
 
 
 
Austin, TX 78731 
 
24-Hour Telephone Number:  
512-427-1100 
 
INTRODUCTION 
You are being invited to take part in a medical research study. Before you decide to 
take part in this study, you should read this document. This document, called an 
informed consent document, explains the study. Please ask as many questions as 
needed so that you can decide if you want to be in the study. 
 
To be in this research study, you cannot already be in another medical research 
study. 
 
You must be honest and complete in providing your medical history. Giving false, 
incomplete, or misleading information about your medical history, including past and 
present drug use, could have very serious health consequences. 
 
The study doctor is being paid by the Sponsor to conduct this research study. 
 
PURPOSE OF THE STUDY  
The purpose of this study is to compare the effect of treatment with Lumega Z®, (a 
medical food containing lutein, zeaxanthin and meso-zeaxanthin, as well as other 
components) with treatment with AREDS2. AREDS 2 is a nutrient formula used for 
age-related vision loss that is available over the counter and marketed by Bausch & 
Lomb as PreserVision® AREDS 2.  Lumega Z is different than PreserVision AREDS 2 in 
that it is available only by prescription and contains additional vitamins, antioxidants, 
and micronutrients. 
 

GUARDiON Health Sciences, Inc.: 1  
Thomas T. Henderson, MD 
Informed Consent 
Page 2 of 6  
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB:  17 JANUARY 2018 
 
 
 
 
 
 
 
 
 
Patients with early signs of age-related vision loss (defined for this study as having 
yellow deposits in the retina and no or mild abnormality of dark adaptation) that 
take one of the two treatments (PreserVision AREDS 2 or Lumega Z) will be 
compared with those with normal dark adaptation and with the other treatment 
group. 
 
WHAT WILL HAPPEN DURING THE STUDY 
Each potential patient will undergo a screening test called AdaptDx to identify 
patients with normal dark adaptation and those with abnormal adaptation. AdaptDx 
is a machine used to test dark adaptation that involves looking into a dark field and 
recognizing when a light appears.  All patients will receive the same exams at 
baseline, three months and six months (for details see listing below).  
 
Those who are confirmed as normal dark adaptation will receive no treatment 
because they do not need this treatment. Those who are confirmed with a few 
drusen on Visucam photography and mild dark adaptation difficulty (less than or 
equal to 10 minutes on the AdaptDx) will receive one of two treatments below for 6 
months: 
 
x 
Lumega Z, a medical food, containing all 3 macular pigments, 10 mg lutein, 
15 mg meso-zeaxanthin, 3mg zeaxanthin as well as essential cofactors and 
other antioxidants 
x 
PreserVision AREDS 2 containing 10mg lutein, 2 mg zeaxanthin 
 
The treatment assigned to you will be assigned by chance. You have a 2 in 3 
chance of being assigned to Lumega Z or 1 in 3 chance to be assigned to 
PreserVision AREDS2. If positive effects are noted it is possible that the study may 
be extended. The tasks below are part of standard diagnostic clinical eyecare 
practice. 
 
x 
Baseline, 3 month and 6 month examinations  
 
Medical History 
Best corrected visual acuity 
Best corrected contrast sensitivity (CSV-1000) 
Intraocular pressure, non dilated slit lamp exam 
Dark adaptation (AdaptDx, extended exam) 
Macular Pigment Optical Density (Mapcat SF) 
Macular Ocular Coherence Tomography (Cirrus OCT) 
Fundus Photography (Zeiss Procam)  
 
If the Sponsor determines there is a need to extend the study, you may be asked 
to attend extra visits, although this is not required.   
 

GUARDiON Health Sciences, Inc.: 1  
Thomas T. Henderson, MD 
Informed Consent 
Page 3 of 6  
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB:  17 JANUARY 2018 
 
 
 
 
 
 
 
 
 
LENGTH OF THE STUDY AND NUMBER OF PARTICIPANTS EXPECTED TO TAKE 
PART 
Approximately 90 participants, ages 60 through 80, are expected to be in this 
study. The study will last for six months. At any point during the study, you may 
choose to withdraw with absolutely no penalty or questions asked. Your withdrawal 
will not jeopardize your relationship with the study doctor or the study staff at his 
clinic.  
 
SIDE EFFECTS AND OTHER RISKS 
There are no known side effects for the nutrients to be taken for this study.  Lutein, 
zeaxanthin and meso-zeaxanthin have been studied in several thousands of people 
at various doses with no reports of side effects.  Additionally, leutein, zeaxanthin and 
meso-zeaxanthin have no known drug interactions. 
 
You must be honest in reporting anything out of the ordinary that you may 
experience during the study. There is a possibility that you may experience side 
effects from these nutrients. 
 
UNFORESEEABLE RISKS  
As noted above, there are no known risks associated with any of the procedures in 
the study. However, there is always a possibility that you may experience a side 
effect during the study. We ask that you please tell us if you believe this to be the 
case so that we can properly address the issue.  
 
POSSIBLE BENEFITS OF THE STUDY 
Lutein, zeaxanthin and meso-zeaxanthin could significantly reduce your risk for 
developing age-related macular degeneration or may delay, halt or even reverse 
the progression of the disease at its very earliest stages. You may also experience 
improvement in visual performance by participating in this study. Even if the study 
does not benefit you, this study could benefit other patients in the future.  You will, 
receive a six months supply of lutein, zeaxanthin or lutein, zeaxanthin and meso-
zeaxanthin at no cost. 
 
PAYMENT FOR BEING IN THE STUDY  
You will not be paid for being in this study.  
 
ADDITIONAL COSTS 
You do not have to pay for the specific study supplements.  If the examinations 
conducted during the study would be conducted as a part of the routine care for 
macular degeneration, they would be submitted to your insurance plan and you 
would be responsible as usual, for expenses under deductibles and copays. 
 
ALTERNATIVES TO PARTICIPATION 
There are other treatments available if you decide not to be in the study. 
   

GUARDiON Health Sciences, Inc.: 1  
Thomas T. Henderson, MD 
Informed Consent 
Page 4 of 6  
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB:  17 JANUARY 2018 
 
 
 
 
 
 
 
 
 
x 
You may choose to buy available supplements containing Lutein, 
zeaxanthin and meso-zeaxanthin. 
 
x 
You may choose not to take any supplements at all. 
 
RELEASE OF MEDICAL RECORDS AND PRIVACY 
Your study records will be kept private. There may be times when the study doctor 
will not be able to guarantee privacy, such as when your study medical records are 
requested by a court of law or when shared with a firm in another country that does 
not have privacy regulations in place. Salus IRB and accrediting agencies may 
inspect and copy your records, which may have your name on them. Therefore, 
your total privacy cannot be guaranteed. If information from this study is published 
or presented at scientific meetings, your name and other personal information will 
not be used. The following people will have access to your study records: 
 
x 
Study Doctor 
x 
Study Monitor or Auditor 
x 
Sponsor Company or Research Institution 
x 
Salus IRB 
x 
Other State or Federal Regulatory Agencies 
 
Salus IRB has approved this study and this informed consent document. Salus IRB is 
a committee of scientific and non-scientific individuals who review, require 
modifications to, and approve or disapprove research studies by following the federal 
laws. This group is also required by the federal regulations to provide periodic review 
of ongoing research studies. 
 
IN CASE OF AN INJURY RELATED TO THIS RESEARCH STUDY 
You must tell your study doctor if you feel that you have been injured by taking 
part in this study. You can tell the study doctor in person or call the number listed 
on the first page of this consent document. You will be treated with the same care 
that any other patient would receive if they suspected a side effect from treatment. 
No form of compensation is offered for a research related injury. 
 
LEGAL RIGHTS 
You do not lose any legal rights by signing this consent document. The above 
statement, “In Case of an Injury Related to This Research Study,” does not stop you 
from seeking legal help in case of negligence. 
 
NEW FINDINGS  
During the study, you will be told of any important new findings about the nutrients 
used in the study. You can then decide if you still want to be in the study. 
 
 

GUARDiON Health Sciences, Inc.: 1  
Thomas T. Henderson, MD 
Informed Consent 
Page 5 of 6  
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB:  17 JANUARY 2018 
 
 
 
 
 
 
 
 
 
WHOM TO CONTACT 
You may contact the study doctor or study staff at the phone number listed on the 
first page of this consent document: 
 
 
• 
for answers to questions, concerns, or complaints about this research study,  
 
• 
to report a research related injury, or 
 
• 
for information about study procedures. 
  
If you need medical attention please go to the nearest emergency room. 
 
You may contact Salus IRB if you: 
 
x 
would like to speak with someone unrelated to the research, 
x 
have questions, concerns, or complaints regarding the research study, or  
x 
have questions about your rights as a research participant. 
 
Salus IRB 
 
2111 West Braker Lane, Suite 400 
Austin, TX 78758 
Phone: 855-300-0815 between 8:00 AM and 5:00 PM Central Time 
Email: salus@salusirb.com 
 
If you would like additional information about your rights, research in general, or 
IRBs, you may visit www.salusirb.com. 
 
LEAVING THE STUDY  
Taking part in this study is your choice. You may choose either to take part or not 
to take part in the study. You have the right to leave this study at any time. If you 
do not want to be in the study, there will be no penalty to you, and you will not lose 
any benefits to which you are otherwise entitled. 
 
If you wish to leave this study, please call the study doctor or study staff at the 
telephone number listed on the first page of this consent document to schedule study 
exit procedures. 
 
Your part in this study may be stopped at any time without your permission. The 
following people can stop your participation and/or the study itself: 
 
 
• 
Study Doctor 
• 
 
Sponsor Company 
 
• 
Salus IRB 
 
• 
Regulatory Agencies 
 
 
If you do not follow the study procedures you may be taken out of the study. 

GUARDiON Health Sciences, Inc.: 1  
Thomas T. Henderson, MD 
Informed Consent 
Page 6 of 6  
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB:  17 JANUARY 2018 
 
 
 
 
 
 
 
 
 
 
If you withdraw from the study, no new data about you will be collected for study 
purposes. The study doctor will inform you whether he/she intends to either: (1) 
retain and analyze already collected data relating to you up to the time of your 
withdrawal; or (2) honor your request that your data be destroyed or excluded 
from any analysis. 
 
AGREEMENT TO BE IN THE STUDY 
This consent document contains important information to help you decide if you want 
to be in this study. If you have any questions that are not answered in this consent 
document, please ask the person explaining this document or one of the study staff.   
 
By consenting to participate you agree that you have been given a copy of all pages 
of this consent document. You have had an opportunity to ask questions and 
received satisfactory answers to all your questions about this study. You understand 
that you are free to leave the study at any time without having to give a reason and 
without affecting your medical care. You understand that your study-related 
medical records may be reviewed by the company sponsoring the study and by 
government authorities. 
 
 
 
IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, 
YOU SHOULD NOT SIGN THIS INFORMED CONSENT DOCUMENT. 
 
 
 
 
Printed Name of Participant 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
 
 
Date 
 
 
 
Printed Name of Person Explaining Informed Consent Document 
 
 
 
 
 
Signature of Person Explaining Informed Consent Document          
Date 
 
 
 
FOR Salus IRB USE ONLY 
Initial draft 
cas: 02Nov17 
tla: 17Jan18 
 
 

                                       
 
 
 
 
                                CONTROLLED STUDY OF THE EFFECT OF A MEDICAL FOOD CONTAINING 
                                ALL THREE MACULAR CAROTENOIDS AND ESSENTIAL COFACTORS COMPARED  
                                TO AREDS2 ON EARLY MACULAR DEGENERATION 
 
Sponsor:               GUARDiON HEALTH SCIENCES, Inc. 
                               15150 Avenue of Science, Suite 200 
                               San Diego, California 92128 
                               (800) 873-5141 
                               Gordon Bethwaite 
                               Vice President, Sales and Marketing 
 
Investigator:       Thomas T. Henderson, MD 
                              3410 Far West Blvd. Suite 140 
                              Austin, TX 78731 
                              (512) 427-1100 
 
Study Product:   Lumega-Z Advanced Ocular Health Medical Food 
 
Protocol Number: 1 
                                  Version 2 
                                 27 DEC 2017 
       
 
 

 
  
                    Controlled Study of the Effect of a Medical Food 
Containing All Three Macular Carotenoids and Essential Cofactors  
Compared to AREDS2 on Early Macular Degeneration 
 
PURPOSE: 
This 6-month randomized control study is undertaken to compare the effect of treatment with 
LumegaZ, a medical food containing lutein, zeaxanthin, and meso-zeaxanthin, as well as 
essential cofactors, other antioxidants, and mitochondrial support, with the effect of treatment 
with AREDS2.  Patients with early macular degeneration, defined as photographically visible 
drusen with or without abnormal dark adaptation on the AdaptDx will be randomized 2:1 and 
both groups will be compared to untreated patients with normal dark adaptation. 
 
BACKGROUND: 
Macular degeneration is the most common cause of blindness in people over the age of 60.  
The incidence of macular degeneration at all stages is 1 in 8 and is more common than diabetes 
and glaucoma at the same age. 
The dietary carotenoids lutein and zeaxanthin (derived primarily from leafy green vegetables 
and other colored fruits and vegetables) as well as meso-zeaxanthin, a metabolite of lutein, are 
stored in the macula in all healthy retinas.  This area serves central vison, and is the specific 
area that is affected by macular degeneration.  The accumulation of these pigments results in a 
yellowish coloration of the retina, the concentration of which is called macular pigment density.  
A large multicenter trial called AREDS 2 (2013) showed that supplementing lutein and 
zeaxanthin reduced progression of moderate to advanced AMD by 25%.  The CREST (2014) and 
MOST (2015) studies showed that supplementation of all 3 macular pigments resulted in 
normalization of the macular pigment profile and improvement in contrast sensitivity in early 
AMD.  All 3 macular carotenoids are recognized by the FDA as ‘generally regarded as safe 
(GRAS) for supplementation in foods. 
Macular degeneration can be understood as a disease of excessive oxidation of the retinal 
tissue with genetic, age, dietary and light exposure components leading to accumulation of 
oxidized cholesterol and polyunsaturated fatty acids both on Bruch’s membrane and between 
Bruch’s membrane and the retinal pigment epithelium in a condition analogous to plaque 

buildup in arteries.  These deposits block transfer of waste out of the retina leading to more 
accumulation and block transfer of nutrients into the retina.  In macular degeneration, not 
enough Vitamin A crosses Bruch’s membrane because of the build-up, causing a localized 
deficiency of Retinol in the parafoveal rods. This causes slower dark adaptation after bleaching 
light, which is the earliest symptom of macular degeneration: difficulty driving in darkness or 
adapting to dark conditions increasing with aging.  
Abnormal dark adaptation found by AdaptDX testing is the earliest clinical sign of macular 
degeneration. This has enabled diagnosis of subclinical macular degeneration with 90% positive 
and negative test reliability, 3-5 years before the first drusen is visible clinically. Those patients 
who exhibit impaired dark adaptation, whether they are subclinical with no drusen or early with 
mild drusen, may benefit from nutritional and /or lifestyle changes which could significantly 
slow the progression of the disease.  This would result in maintenance of retinal health and 
visual performance. 
It is clear that early, effective intervention in any disease process is the key to reducing 
morbidity.  Earlier diagnosis of macular degeneration is now possible with AdaptDX testing.  
Effective intervention involves reducing the photo-oxidative damage of the retina caused by the 
visual process in the retina, and potential clearing of the early stage blockage of bidirectional 
transport across Bruch’s membrane. Thirty percent of people over age 60 have abnormal dark 
adaptation.  Likewise, 30% of people have an abnormal spatial profile of macular pigment 
indicating insufficient meso-zeaxanthin creation from lutein.  Supplementing meso-zeaxanthin 
as well as lutein and zeaxanthin can restore the macular pigment spatial profile and improve 
visual performance in early macular degeneration.  Early results from an as yet unpublished 
exploratory study in progress with such supplementation in subclinical AMD indicate 
improvement in MPOD and best corrected contrast sensitivity in many patients by 6 months.  
A medical food is a special category of supplement approval by the FDA where physicians 
prescribe it for nutritional treatment of specific medical conditions.  The medical food to be 
used by patients in this study contains not only all the macular carotenoids in micelle 
formulation for improved absorption, but also significant cofactors, such as vitamins, minerals, 
ALA, astaxanthin, N-acetylcysteine, carnosine and others.  All of these ingredients working 
together should significantly improve the mitochondrial, antioxidant and anti-inflammatory 
functions of the retina.  This should allow creation of less damage to critical elements of the 
retina and less toxic waste such as oxidized cholesterol and oxidized polyunsaturated fatty acids 
which are the major components of the sub-RPE and Bruch’s membrane deposits.  This 
controlled study will attempt to show that using a medical food designed to optimize retinal 
metabolism and antioxidant capacity will exert a positive effect in subclinical macular 
degeneration, which is greater than supplementation with AREDS2 and will also improve 
measured functions into the range of function in untreated normal patients. 
 

STUDY:  
All study candidates are routine patients in a general ophthalmology practice. All patients who 
are interested will be offered the opportunity to participate in this controlled study of the 
effect of a nutritional food on subclinical macular degeneration. Each patient will undergo a 
screening AdaptDx to separate patients with normal dark adaptation from those with abnormal 
dark adaptation. All patients will receive the same exams at baseline, 3 months and 6 months. 
For details, see the listing below. Those who are confirmed as normal with extended dark 
adaptation testing will receive no treatment precisely because they are defined as not having a 
problem needing this treatment.  Those who are confirmed with early macular degeneration by 
photographically visible drusen and have dark adaptation scores of less than 10 minutes will 
receive treatment by ingesting a commercially available medical food, containing all 3 macular 
pigment as well as essential cofactors and other antioxidants, or AREDS2,randomized 2:1 for 6 
months.  If positive effects are noted, it is possible that the study might be extended. The tasks 
below are part of standard diagnostic clinical eyecare practice.  
x Baseline, 3 month and 6 month examinations 
o History 
o Risk factors 
o Best corrected visual acuity 
o Best corrected contrast sensitivity (CSV 1000) 
o Intraocular pressure, nondilated slit-lamp exam 
o Dark adaptation (AdaptDX, extended exam) 
o Macular pigment optical density (MapcatSF) 
o Macular ocular coherence tomography (Zeiss Cirrus OCT) 
o Fundus photography (Zeiss VisuCam Pro) 
 
Because these patients will have additional problems found in routine clinical practice, other 
exams may occur for other problems and will not be considered part of the study data.  Should 
any adverse effects be noted thought to be from the study treatment, the patient will be 
examined to understand the effect and if it is felt to be not significant, the patient will be asked 
to continue in the study. In the highly unlikely event a serious adverse effect is noted the 
patient will be terminated from the study and appropriate treatment will be undertaken. 
 
DATA COLLECTION: 
The data will be maintained on standardized forms and printable graphics, as well as in the 
patient’s routine clinical file.  To protect identifiable information, files will be locked in a file 
cabinet, accessible only the PI and the study coordinator. Data will be transcribed without 

personally identifiable information into standard Excel files and analyzed as appropriate using 
standard statistical techniques.  
STUDY REQUIREMENTS: 
This study will be conducted with the protocol, good clinical practices and applicable regulatory 
requirements. This is a no significant risk study, using commercially available supplements, 
Lumega-Z or AREDS2, containing 2 or 3 of the three carotenoids that are FDA “generally 
recognized as safe” for food supplementation and are found in all healthy retinas. All 
examinations are noninvasive and are performed with FDA cleared, commercially available 
medical devices in routine clinical use.  
The study population consists of 90 male and female patients in a routine clinical practice age 
60 and over who have early macular degeneration as defined as a few drusen visible on 
Visucam and have an AdaptDx score less than or equal to 10 minutes. No vulnerable 
populations will be studied.  
The patient will be studied for improvements in ocular function. Primary endpoints would be 
improvement in macular pigment optical density long form, improvement in best corrected 
contrast sensitivity and improvement in best corrected vision. Secondary endpoints would be 
improvement of AdaptDx long form time  or a reduction in drusen.   
The study supplements for each  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
study subject will be kept in a locked cabinet until dispensed by study staff not involved with 
testing to the subject.  
A protocol deviation log and an adverse effect log will be kept for each subject. Immediate 
attention will be paid to any serious adverse events, which by the nature of the study are 
completely unexpected. If any injuries occur to subjects in the protocol , they are considered to 
be under treatment for early AMD, (diagnosis AMD, ICD H35.3131) and will be dealt with as any 
other medical condition or complication of treatment.  
Data will be reviewed for safety and unexpected positive or negative effects after three and six 
month visit period are completed for all subjects.  
Data will be collected in the subjects routine electronic medical record and confirmed as  
complete on a hard copy visit log in a study folder for each subject. Copies of each visit will be 
kept in the study folder. There will be a protocol deviation log, adverse events log and a study 
supplement log in each subjects folder. 
The information collected will be used in anonymous group data analysis to be prepared for 
submission for potential publication. The information will not be sold or used in future 
research. The data can be verified through the audit trail in the subject’s individual electronic 
medical record original source. No data will be stored on a portable device. The data will not be 
destroyed because it is part of medical record of care of AMD unspecified for an individual  and 
is subject to the laws of the state of Texas and the rules of the state medical board.  

Statistical Analysis Plan 
 
 
At the end of the trail period, data will be collected by the 
Principal Investigator and analyzed by professional optical 
engineers at Western University of Health Sciences, Pomona CA.  
The data provided will only contain patient ID, age, and sex, 
without containing any identifying details about each participant. 
Data will be analyzed upon measurement quality, according to 
the respective manufacturer procedures, in each outcome 
measure. In the event which data is missing or incomplete, we 
will evaluate the appropriate measures to include the available 
information and consult with qualified professionals. 
 
Preliminary and sub-analyses will be performed using the 
statistical programing software, SPSS Systems. The objective is 
to examine the distribution and potential relationships within data 
sets through standardized descriptive-numerical summaries. 
Statistical analysis strategies may include a mixed-design 
Analysis Of Variance (ANOVA) to examine the following outcome 
measures across the three time-points of data collection; 
including visual acuity, contrast sensitivity, dark adaptation 
recovery, and MPOD levels. A post hoc sub-analysis of paired 
sample t-test may be used (either Bonferroni correction or Tukey 
test) to evaluate the change in each outcome measure 
parameter, if needed, in respect to each treatment group. 
Additionally, each group-measurement may be separated and 
analyzed by eye; to evaluate inter-eye differences from each 
treatment. Results of the statistical analysis will be analyzed as 
group averages of each outcome measurement. 
Oct 23, 2018
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