Clinical trial NCT05292755
Conditions: Dry Eye Syndromes
Sponsor: University of Florida
Start date: 2022-04-22; Completion date: 2022-07-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Carboxymethylcellulose (CMC), a common component in artificial tears, has been shown to modify the gut microbiome. The study is examining its effects on the eye microbiome, which may have implications on ocular disease and artificial tear choice. The study will administer artificial tears containing CMC to the treatment group and artificial tears without CMC to the control group. Surveys and conjunctival swabs will be collected before and after treatment for bacterial genome sequencing and analyzed by R statistical packages.

Detailed description:

Arms: arm 1: Refresh brand artificial tears containing 0.5% carboxymethylcellulose will be self-administered three times a day in each eye by the participants for 1 week in the experimental arm. arm 2: Systane brand artificial tears containing 0.4% polyethylene glycol 400 and 0.3% propylene glycol will be self-administered three times a day in each eye by the participants for 1 week in the control arm.
Interventions: intervention 1: Carboxymethylcellulose (CMC) Artificial Tears intervention 2: Preservative-free, CMC-free Artificial Tears (control)
Intervention descriptions: intervention 1: A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group. intervention 2: A pack of 21 vials of artificial tears containing 0.4% polyethylene glycol 400 and 0.3% propylene glycol will be given to subjects in the control group.

Protocol documents:
Prot_SAP_000.pdf: 
Clinical Trial: Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome 
NCT: 05292755 
 
Study Protocol and Statistical Plan 3/31/2022 
 
• Principal Investigator: Yujia Zhou, M.D. 
• Co-Investigator: Elizabeth Dawson 
• Co-Investigator: Gary Wang, M.D., Ph.D. 
• Supervisor: Walter Allan Steigleman, M.D. 
 


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University of Florida IRB-01 
Protocol 
 
 
1. Title: 
Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: A 
Randomized, Controlled, Double-Blind Study 
2. Investigators: 
• Principal Investigator: Yujia Zhou 
• Co-Investigator: Elizabeth Dawson 
• Co-Investigator: Gary Wang, M.D., Ph.D. 
• Supervisor: Walter Allan Steigleman, M.D. 
3. Abstract: 
Carboxymethylcellulose (CMC), a common component in artificial tears, modifies the gut 
microbiome when ingested. We will identify its effects on the eye microbiome of adult UF 
eye clinic patients in this randomized, controlled, double-blind study. Effects of CMC on 
the eye microbiome are unknown and have implications for ocular disease and artificial 
tear choice. Participants will be given either CMC artificial tears or artificial tears without 
CMC, complete symptom surveys, and undergo conjunctival swabs. Investigators will 
conduct chart reviews, bacterial genome sequencing, and analyze microbiomes using 
Shannon’s diversity index and principal coordinate analysis on R statistical packages. 


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4. Background:  
Carboxymethylcellulose (CMC) is a thickener frequently included in FDA-approved 
artificial tears. A study by Chassaing et al. in 2021 entitled “Randomized Controlled-
Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental 
Impacts on the Gut Microbiota and Metabolome” demonstrated that CMC ingestion 
alters the gut microbiome. The eye also has a microbiome distinct from other organ 
systems. The ocular microbiome influences eye diseases including dry eye disease 
and keratitis, as summarized in an article entitled “Microbes of the human eye: 
Microbiome, antimicrobial resistance and biofilm formation” by Ranjith et al. in 2021. 
Interventions such as contact lens wear can change the diversity and composition of 
eye bacteria, as demonstrated in an article entitled “Changes in the Eye Microbiota 
Associated with Contact Lens Wearing” by Hakdong et al. in 2016. 
Therefore, we hypothesize that the use of CMC in artificial tears may affect the eye 
microbiome and influence ocular diseases. Similar studies on microbiome composition 
used bacterial ribosomal RNA sequencing and statistical analysis with existing R 
packages such as phyloseq and DADA2. A UF investigator, Rachel Newsome, recently 
conducted a microbiome study entitled “The gut microbiome of COVID-19 recovered 
patients returns to uninfected status in a minority dominated United States cohort” at 
the University of Florida in 2021. For these reasons, we are conducting a similar study 
on the use of artificial tears containing CMC compared to control artificial tears without 
CMC. Results of this study will lead to a better understanding of the risks and benefits 
associated with CMC artificial tears for eye lubrication and dry eye disease. 
5. Specific Aims: 
We aim to examine whether carboxymethylcellulose in artificial tears changes the eye 
microbiome and identify which bacterial genera are enriched. 
6. Research Plan:  


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• Recruitment: During the spring of 2022, 80 patients of the UF Oaks Eye Clinic who 
meet inclusion criteria will be identified by study staff prior to their visit by chart 
review using the Epic electronic medical record and clinic scheduler on a secure 
encrypted UF computer. Up to 20 participants are expected to drop out over the 
course of this study. When patients have completed their clinical workup, Dr. 
Steigleman will approach patients without exclusion criteria to ascertain 
willingness/interest in the study, then recruit them. Study staff will give willing 
participants the appropriate informed consent form and counsel participants for 
consent to enroll in a private examination room. Completed consent forms will 
labelled with the participant’s randomly selected numerical identifier as described 
below and stored securely in the UF Oaks Eye Clinic Office. 
• Participant Criteria: This study includes adults above age 18 of either sex who 
can self-administer artificial tears and are scheduled to return for clinical follow-up 
in 1 week. This study excludes individuals with active eye infections, have 
prosthetic eyes, are immunocompromised, or are diagnosed with autoimmune 
diseases or malignant neoplasms about the eye. Individuals who take 
immunomodulatory therapy, steroids, antibiotics, medicated eyedrops, or are 
already using CMC artificial tears within 1 week of the study will also be excluded. 
These criteria maximize the number of self-consenting participants while minimizing 
participants whose compliance, conditions, or medications may change the eye 
microbiome. 
• Research Intervention: Participants will be given either artificial tears without CMC 
(control) or commercial artificial tears containing CMC (treatment) and told that they 
may have received either CMC or a placebo. Both are FDA-approved for over-the-
counter use and for treatment of dry eye. Both interventions are standard therapies 
for dry eye disease. Prospective participants have the option to not enroll in the 
study, and the alternative is to complete a normal clinic visit. Individuals for whom 
artificial tears do not constitute standard therapy are excluded from this study. 
• Assignment: This study design will include an experimental control, random 
assignment, and double blinding of staff and participants. The principal investigator 
will create a securely saved Excel spreadsheet with unique randomly generated 
numerical identifiers keyed to either the control group receiving artificial tears 
without CMC or the treatment group receiving CMC artificial tears. The principal 
investigator will then create plain cardboard boxes with the identifier on removable 
adhesive labels. Boxes will contain a copy of the informed consent form, participant 
instructions, and 21 plastic vials of either artificial tears without CMC or CMC 
artificial tears as assigned on the identifier spreadsheet. Patients will be blinded to 
their assigned intervention group. Study staff other than the principal investigator, 
who are blinded to box contents, will give participants a randomly selected box and 
an electronic survey (PDF) on an encrypted clinic computer in their private 
examination room. Labels will be placed on consent forms and identifiers will 
replace personal identifying information on electronic surveys. 
• Data Collection: Electronic surveys will contain the Ocular Surface Disease Index 
and a box for entry of the patient’s unique identifier. After completion of the survey, 
licensed physicians serving as study staff will swab the participant’s right and left 
eye conjunctiva with a single cotton tip applicator, seal the applicator in a sample 


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tube, attach a label, and freeze it for storage in dry ice. The participant will complete 
a normal clinical schedule afterwards and will be scheduled to return in 1 week. 
Upon 1 week follow-up, participants will be swabbed again and complete a second 
survey. The second survey will be identical to the first survey but contain an 
additional question quantifying eye drop use to measure compliance. Patients will 
complete a normal clinical schedule afterwards. Study staff will correlate identifiers 
to patients using the informed consent forms and record ophthalmic history, 
ophthalmic medications, age, gender, tobacco usage, diabetes status, and race by 
chart review during this study. 
• Sample Processing and Data Analysis: Samples will be frozen at -80 degrees 
Celsius and transported to a BSL-2 lab at UF for processing. During processing, 
samples will be lysed, amplified, and sequenced for bacterial 16S RNA using 
protocol supplied by Illumina MiSeq. Swabs and container tubes will be destroyed 
after sequencing. The sequenced bacterial microbiome of each sample will then be 
trimmed, error-corrected, and classified using the DADA2 R package as described 
in the article described above (Newsome 2021). After all samples are sequenced, 
microbiomes will be grouped by principal coordinate analysis using the phyloseq R 
package. Shannon’s diversity indices will be calculated using the phyloseq R 
package. Differences in alpha diversity before and after treatment will be tested by 
PERMANOVA using the vegan R package, and differences in beta diversity will be 
tested by ANOVA using the nlme R package. 
• Data Security: The original consent forms with unique identifier stickers will be 
kept securely in a folder and stored in a locked office within the UF Oaks Eye Clinic. 
Surveys will be accomplished on a pdf and do not contain any participant 
identification aside from the study-assigned numerical identifier. All other 
documents and data files will be deidentified and stored on an encrypted computer 
within the UF IT environment. Only medical students, resident physicians, and 
attending physicians serving as study staff will access participant medical records 
on the Epic EMR using a secure encrypted computer or smartphone. This study will 
not have a Data Safety Monitoring Board. Dr. Steigleman will serve as oversight for 
this research project and will meet weekly with study staff to monitor study conduct 
and patient safety. 


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7. Possible Discomforts and Risks: 
Enrolled study participants may more commonly encounter mild eye discomfort during 
conjunctival swabs, anxiety regarding assignment to a treatment group, short delays in 
clinic flow (1-2 minutes), and inconvenience of completing surveys during the study. 
Rare discomforts or risks may include breach of protected patient data, eye pain, dry 
eye, eye infection, and eye trauma including corneal abrasions and conjunctival 
hemorrhage because of methods used in this study. Participants will not be charged for 
any time, medication, or procedure used in this study. 
To minimize anxiety and medical risks, patients will receive counseling and treatment 
interventions in the setting of the UF Oaks Eye Ophthalmology Clinic by a licensed 
attending ophthalmologist or an ophthalmology resident capable of mitigating and 
treating such harms. The inconvenience of enrolling in the study will be mitigated by 
utilizing the wait time (10 to 40 minutes) during a routine clinic appointment. The 
conjunctival swab is a routine technique practiced by attending and resident 
ophthalmologists with minimal risk. Eye discomfort and pain during this procedure will 
be reduced with a soft cotton-tip applicator, and patients may be given routine topical 
anesthetics or eye lubricants after the procedure if needed. Topical anesthesia prior to 
swabbing and other methods of collecting microbiome samples such as eye irrigation 
will not be used due to their anticipated negative effect on sample quality. 
8. Possible Benefits: 
The participants will receive free FDA-approved treatment (artificial tears) for dry eye 
during the study and improved guidance on artificial tear choice after the study’s 
conclusion based on the study results. This may not benefit all participants directly but 
may directly help some participants alleviate dry eye. There are no other direct benefits 
to participants. 
To date, there is no data on whether this common artificial tear ingredient may have 
deleterious or favorable effects on the eye microbiome. The composition of eye 
microbiomes has been shown to have associations with eye diseases, including dry 
eye disease. This information may guide artificial tear choice in the future, as opposed 
to the status quo, where all brands of preservative-free artificial tears are treated as 
equivalent. 
These benefits outweigh the minimal risk to enrolled study participants, who will be in 
the care of a trained ophthalmologist during the length of this study in the unlikely 
event that harm occurs to them. Our study methods use minimally invasive techniques 
to gather data and are routine in the setting in an ophthalmology clinic. We designed 
the study such that the risk of unreasonable harms such as billing for research time, 
eye infections, and patient discomfort are minimized or eliminated. 
9. Conflict of Interest: 
We do not have any conflicts of interest to disclose. Neither the principal investigator, 
co-investigators, or UF hold patents, licenses, or stock in the artificial tears used. We 
have no external sponsors. 
 

ICF_001.pdf: 
Clinical Trial: Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome 
NCT: 05292755 
 
Informed Consent Form 3/31/2022 
 
• Principal Investigator: Yujia Zhou, M.D. 
• Co-Investigator: Elizabeth Dawson 
• Co-Investigator: Gary Wang, M.D., Ph.D. 
• Supervisor: Walter Allan Steigleman, M.D. 
 


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INFORMED CONSENT FORM 
to Participate in Research, and 
AUTHORIZATION  
to Collect, Use, and Disclose Protected Health Information (PHI) 
 
INTRODUCTION 
Name of person seeking your consent:  
 
 
 
 
 
 
 
 
 
 
 
Place of employment & position:  
 
 
 
 
 
 
 
 
 
 
 
 
GENERAL INFORMATION ABOUT THIS STUDY 
1. Name of Participant ("Study Subject") 
___________________________________________________________________  
_________ 
2. What is the title of this research study (this “Research Study”)? 
Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: A Randomized, Controlled, 
Double-Blind Study 
3. Whom do you call if you have questions about this Research Study (the “Study Team”)? 
Principal Investigator: Yujia Zhou - (305) 342-9166 
Faculty Supervisor: Dr. Walter Steigleman - (352) 265-2020 
Coinvestigator: Elizabeth Dawson (please call the above numbers) 
Coinvestigator: Dr. Gary Wang (please call the above numbers) 
4. Who is paying for this Research Study? 
The sponsor of this study is the UF Ophthalmology Department. 
5. In general, what do you need to know about this Research Study? 
Agreeing to become involved in any research is always voluntary. By signing this form, you are not waiving 
any of your legal rights. If you decide not to participate in this research, you will not be penalized in any 
way and you will not lose any benefits to which you are entitled. If you have questions about your rights as 
a research subject, please call the University of Florida Institutional Review Board (IRB) office at (352) 273-
9600.  
a) In general, what is the purpose of the research? How long will you be involved?  
The purpose of this research study is to identify the effects of carboxymethylcellulose artificial tears on 
your eye bacteria. Carboxymethylcellulose is a common food and drug ingredient which affects the gut 
microbiome, but we have no knowledge of how it affects the eye. This experiment will analyze your 
eye bacterial population before and after using artificial tears and will last one week. 


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b) What is involved with your participation, and what are the procedures to be followed in the 
research?  
At your first clinic visit, we collect an eye swab from both of your eyes and ask you to complete a short 
survey about any symptoms you may have related to dry eye. Afterwards, we will ask you to use a 
specific type of artificial tears for and return for follow-up to get a second eye swab and complete a 
second survey. This process involving follow-up will take one week from your first appointment to the 
second appointment. You will receive a week’s supply of either SystaneTM or RefreshTM artificial tears 
for free, but you will not be told which tears you have received. 
c) What are the likely risks or discomforts to you?  
You may encounter mild eye discomfort during conjunctival swabs, anxiety regarding assignment to a 
treatment group, short delays in clinic flow (1-2 minutes), and inconvenience of completing surveys 
during the study. Rare discomforts or risks may include breach of protected patient data, eye pain, dry 
eye, eye infection, and eye trauma including corneal abrasions and conjunctival hemorrhage because 
of methods used in this study. You will not be charged for any time, medication, or procedure used 
specifically for this study. 
d) What are the likely benefits to you or to others from the research? 
You will receive a week’s supply of artificial tears or saline eye drops for free. We will use the 
information from this study to determine whether it is safe and effective to use 
carboxymethylcellulose artificial tears. Other people using artificial tears may be able to use this 
information to choose the right brand for them. 
e) What are the appropriate alternative procedures or courses of treatment, if any, that might be 
helpful to you?  
You have the option to not enroll in the study and complete a normal clinic visit, where you will be 
treated for any eye ailments appropriately. 
Additional and more detailed information is provided within the remainder of this 
Informed Consent form. Please read before deciding if you wish to participate in 
this study. 
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY? 
6. What will be done as part of your normal clinical care (even if you did not participate in this 
Research Study)?  
You will have a normal clinic visit at the UF Oaks Eye Center with a board-certified ophthalmologist and 
receive appropriate clinical care for your eye complaints. This may include antibiotics for eye infections, 
refractive prescriptions for refractive errors, and eye surgery as indicated by your conditions and 
symptoms. 
7. What will be done only because you are in this Research Study?  
You will receive a week’s supply of artificial tears, complete two surveys on dry eye symptoms, and 
undergo two conjunctival swabs. 
If any identifiable information or eye swabs are collected as part of this research, it is possible that your 
research information and eye swabs with all personally identifiable information removed, could be used 


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for future research studies, or distributed to another investigator for future research studies without 
additional informed consent from you or your legally authorized representative. 
If you have any questions now or at any time during this Research Study, please contact one of the 
Research Team members listed in question 3 of this form. 
8. What identifiable health information will be collected about you and how will 
it be used? 
 
The Research Team will collect: 
• 
Name (will not be published or used in data analysis) 
• 
Medical record number (will not be published or used in data analysis) 
• 
Medical diagnoses 
• 
Medication list 
• 
Tobacco use status 
• 
Age 
• 
Sex 
The Research Team may collect this information from other healthcare providers, such as laboratories, 
which are a part of this research, as well as healthcare providers that are not part of this research (other 
doctors, hospitals or clinics). Other professionals at the University of Florida or Shands Hospital who 
provide study-related care, and the University of Florida Institutional Review Board (IRB), may also 
collect your health information.  
The Research Team listed in question 3 above will use or share your health information as described 
below to carry out this research study.  
9. With whom will this health information be shared? 
This health information may be shared with: 
• 
The study sponsor (listed in Question 4 of this form) 
• 
United States governmental agencies which are responsible for overseeing research, such as the 
Food and Drug Administration, the Department of Health and Human Services, and the Office of 
Human Research Protections. 
• 
Government agencies which are responsible for overseeing public health concerns, such as the 
Centers for Disease Control and federal, state and local health departments. 
• 
the IRB that reviewed this Research Study and ensures your rights as a Study Subject are 
protected.  
Otherwise, your identifiable health information will not be shared without your permission unless 
required by law or a court order. Once your health information is shared with those listed above, it is 
possible that they could share it without your permission because it would no longer be protected by 
the federal privacy law.  
10. How long will you be in this Research Study? 
You will be enrolled in this research study for one week, from your first clinic visit to your second visit. 
This Authorization to use and share your health information expires at the end of the study unless you 
revoke it (take it back) sooner. 
11. How many people are expected to take part in this Research Study? 


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Up to 80 people are expected to take part in this research study. 
WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND  
WHAT ARE YOUR OPTIONS? 
 
12. What are the possible discomforts and risks from taking part in this Research Study? 
Enrolled study participants may more commonly encounter mild eye discomfort during conjunctival 
swabs, anxiety regarding assignment to a treatment group, short delays in clinic flow (1-2 minutes), and 
inconvenience of completing surveys during the study. 
Other possible risks to you may include breach of protected patient data, eye pain, dry eye, eye 
infection, and eye trauma including corneal abrasions and conjunctival hemorrhage because of methods 
used in this study 
This Research Study may also include risks that are unknown at this time. 
Please note, participating in more than one research study or project may further increase the risks to 
you. If you are already enrolled in a research study, please inform one of the Research Team members 
listed in question 3 of this form or the person reviewing this consent with you before enrolling in this or 
any other research study or project. 
During the study, the Research Team will notify you of new information that may become available and 
might affect your decision to remain in the study.  
The University of Florida is required by law to protect your health information. Your health information 
will be stored in locked filing cabinets or on computer servers with secure passwords, or encrypted 
electronic storage devices, as required by University policy. However, there is a slight risk that 
information about you could be released inappropriately or accidentally. Depending on the type of 
information, a release could upset or embarrass you, or possibly affect your ability to get insurance or a 
job.  
If you wish to discuss the information above or any discomforts you may experience, please ask 
questions now or call one of the Research Team members listed in question 3 in this form. 
13a. What are the potential benefits to you for taking part in this Research Study? 
You will receive free FDA-approved treatment (artificial tears) for dry eye during the study and improved 
guidance on artificial tear choice after the study’s conclusion based on the study results. This may not 
benefit you if you do not experience dry eye. There are no other direct benefits to participants. 
13b. How could others possibly benefit from this Research Study? 
We will use the information from this study to determine whether it is safe and effective to use 
carboxymethylcellulose artificial tears. Other people using artificial tears may be able to use this 
information to choose the right brand for them. 
13c. How could the Research Team members benefit from this Research Study? 
 
In general, presenting research results helps the career of a researcher. Therefore, the Research Team 
listed in question 3 of this form may benefit if the results of this Research Study are presented at 
scientific meetings or in scientific journals. 


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13d. Will you be allowed to see the research information collected about you for this 
Research Study? 
You may not be allowed to see the research information collected about you for this Research Study, 
including the research information in your medical record, until after the study is completed. When this 
Research Study is over, you will be allowed to see any research information collected and placed in your 
medical record.  
14. What other choices do you have if you do not want to be in this study?  
You have the option to not enroll in the study and complete a normal clinic visit, where you will be 
treated for any eye ailments appropriately. 
You may also refuse to authorize the use of your health information, but if you refuse, you may not be 
allowed to be in this research study or receive any research-related treatment that is only available in 
this research study. However, your decision not to sign this Authorization will not affect any other 
treatment you may be eligible to receive. 
15a. Can you withdraw from this study? 
You may withdraw your consent and stop participating in this Research Study at any time. If you do 
withdraw your consent, there will be no penalty to you, and you will not lose any benefits to which you 
are otherwise entitled. If you decide to withdraw your consent to participate in this Research Study for 
any reason, please contact the Research Team listed in question 3 of this form. They will tell you how to 
safely stop your participation. 
You can also change your mind and take back this Authorization at any time by sending a written notice 
to the Research Team listed in question 3 of this form to let them know your decision. If you take back 
this Authorization, the Research Team may only use and disclose your health information already 
collected for this research study. No additional health information about you will be collected or 
disclosed to the Research Team. However, if you take back this Authorization, you may not be able to 
continue in this study. Please discuss this with a member of the Research Team listed in question #3. 
15b. Can the Principal Investigator withdraw you from this Research Study?  
You may be withdrawn from this Research Study without your consent for the following reasons: 
• 
If you are diagnosed with an eye infection 
• 
If you have not used any of the eye drops given in this study 
• 
If you start taking any other eye drops containing carboxymethylcellulose 
• 
If you start taking any other eye drops containing medication or preservatives 
• 
If you start taking antibiotics 
WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE? 
16. If you choose to take part in this Research Study, will it cost you anything? 
You will not be charged for taking part in this research study. Any time, medication, or procedure 
provided solely for the purpose of this study will come at no cost to you. You will be charged for your 
clinic visit as if you were not taking part in this study. 
17. Will you be paid for taking part in this Research Study? 


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You will not be pair or compensated for taking part in this research study. Artificial tears provided for 
this study are provided at no cost to you but are solely for the purpose of the research intervention. 
18. What if you are injured while in this Research Study? 
If you are experiencing eye pain, flashes of light, or loss of vision, call your emergency department or the 
UF Oaks Eye Center at (352) 265-2020. Otherwise, you will be treated at the Oaks Eye Center for your 
injuries and eye ailments during your normal clinic visit.  
Please contact one of the Research Team members listed in question 3 of this form if you experience an 
injury or have questions about any discomforts that you experience while participating in this Research 
Study. 
SIGNATURES 
As an investigator or the investigator’s representative, I have explained to the participant the purpose, 
the procedures, the possible benefits, and the risks of this Research Study; the alternative to being in 
the study; and how the participant’s protected health information will be collected, used, and shared 
with others:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent and Authorization 
 
 
 
Date 
You have been informed about this study’s purpose, procedures, possible benefits, and risks; the 
alternatives to being in the study; and how your protected health information will be collected, used and 
shared with others. You have received a copy of this form. You have been given the opportunity to ask 
questions before you sign, and you have been told that you can ask questions at any time.  
You voluntarily agree to participate in this study. You hereby authorize the collection, use and sharing of 
your protected health information as described above. By signing this form, you are not waiving any of 
your legal rights. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Consenting and Authorizing 
 
 
 
 
 
Date 
 
 


 
 
 
 


 
 
INFORMED CONSENT FORM COVER SHEET 
EFFECTS OF CARBOXYMETHYLCELLULOSE ARTIFICIAL TEARS 
ON THE EYE MICROBIOME: A RANDOMIZED, CONTROLLED, 
DOUBLE-BLIND STUDY 
 
 
PARTICIPANT ID STICKER: