A Patient Experience Study With ABBV-444 for Symptom Relief and Tolerability
Phase: PHASE3
Conditions: Dry Eye Syndrome
Sponsor: AbbVie

P24-203
Protocol
Version date: 02 February 2023
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Title
A Patient Experience Study with ABBV-444 for 
Symptom Relief and Tolerability
Date of Current Version of 
Protocol
02 February 2023
Sponsor (Responsible Party)
AbbVie
 
NCT05878067

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Study Design
Overall Study Design:
A single center, open-label, single arm study (ABBV-444) enrolling 
approximately 40 patients.
Inclusion/Exclusion Criteria for study population:
Inclusion criteria are as follows;
Written informed consent and written documentation, in 
accordance with the relevant country and local privacy 
requirements, had been obtained prior to any study procedures
Had used artificial tears for dry eyes within the past year
Females of childbearing potential, with a negative pregnancy 
test result at Screening Visit; these patients must have been 
currently using a reliable form of birth control and have 
agreed to use a reliable form of birth control for the duration 
of the study
Screening and Baseline Visits Three consecutive tear break-
in at least 1 eye at Day 7 
(screening)
Grade 1 to 4 (modified National Eye Institute [NEI] Grid, 
score range = 0 to 5) staining in at least 1 area of the cornea (5 
areas examined) or conjunctiva (6 areas examined) that was 
related to dry eye in at least 1 eye at both at Screening and 
Baseline Visits
Was able/agreed to continue to wear existing current spectacle 
correction during the study period (if applicable)
Currently corrected distance visual acuity of at least 20/32 
Snellen equivalent in each eye using the 3-meter LogMar 
chart, with existing spectacle correction (if necessary) at 
Screening Visit
If using any form of topical ophthalmic cyclosporine 
(i.e., RESTASIS®), lifitegrast 5% ophthalmic solution 
(Xiidra®
prior to the Screening Visit and plan to continue without 
change for the duration of the study
patients with primary open-angle glaucoma or ocular 
hypertension (OHT). Patients with primary open-angle 
glaucoma or OHT were included provided they were on stable 
mmHg) in 
both eyes. Any topical IOP-lowering medications must have 
hs prior to Screening Visit date 
and dosage that was not expected to change during the study.
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
   
 

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Was able to follow study instructions and was likely to 
complete all required visits
Exclusion criteria are as follows:
Have uncontrolled severe systemic disease that, in the 
assessment of the investigator, would put safety of the 
participant at risk through participation, or which would 
prevent or confound protocol-specified assessments (e.g.,
hypertension and diabetes, Sjögren's syndrome, rheumatoid 
arthritis, systemic lupus erythematosus, immunodeficiency 
disease, etc.)
Known allergy or sensitivity to the study products or their 
components
Females who were pregnant, nursing, or planning a pregnancy
Females of childbearing potential and who were not using a 
reliable method of contraception
Current enrollment in an investigational drug or device study 
or participation in such a study within 30 days of entry into 
this study at Screening Visit 
Screening Visit 
Patient anticipated contact lens wear during the study, or the 
patient had worn contact lenses in the last 3 months prior to 
Screening Visit 
Any scheduled or planned elective ocular or systemic surgery 
or procedure during the study, which in the investigator's 
opinion, may have impacted the patient's study participation
At the Screening and Baseline visits, either eye has corneal 
staining score of 5 in any of the 5 zones or a total score of > 
19 based on the modified NEI grading scheme (score range = 
0 to 5; graded in 5 zones of the cornea for a total score range 
of 0 to 25) or conjunctival staining score of 5 in any of the 6 
zones based on the modified NEI grading scheme (score range 
= 0 to 5 per zone)
Use of systemic medications (over-the-counter, herbal, 
prescription, or nutritional supplements for dry eyes), which 
may have affected tear film or vision (including but not 
limited to the following: flax seed oil, fish oil, omega-3 
supplements, cyclosporine, antihistamines, cholinergic agents, 
anticholinergics, antimuscarines, beta-blocking agents, 
tricyclic antidepressants, phenothiazines, estrogen-
progesterone, and other estrogen derivatives), unless that 
medication had been used at the same dose for at least 3 
months prior to screening and the dosage was not expected to 
change during the course of the study
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 

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Presence of 1 or more of the following ocular conditions in at 
least 1 eye:
Active ocular infection or non-keratoconjunctivitis sicca 
(KCS) ocular inflammation
Active ocular allergy
History of recurrent herpes keratitis or active disease within 
6 months prior to Screening Visit 
Corneal disorder or abnormality that affected corneal 
sensitivity or normal spreading of the tear film (except 
superficial punctate keratitis)
Severe blepharitis or obvious inflammation of the lid margin,
which in the judgment of the investigator, may have interfered 
with the interpretation of the study results
Keratoconjunctivitis sicca secondary to the destruction of 
conjunctival goblet cells, such as occurs with vitamin A 
deficiency or scarring such as that with cicatricial pemphigoid, 
alkali burns, Stevens-Johnson syndrome, trachoma, or 
irradiation
Substantial non-KCS keratitis with overlying corneal stain or 
other significant corneal findings not directly related to dry 
eye; in addition, patients with dry eye signs/symptoms 
(e.g., filamentary keratitis) of a severity where topical 
monotherapy with an artificial tear would have been 
inappropriate
Occlusion of the lacrimal puncta for either eye, with punctal 
plugs or cauterization < 3 months prior to Screening Visit
History of prior ocular/ophthalmic surgery or trauma, which 
could affect corneal sensitivity and/or tear distribution 
(e.g., cataract surgery, laser-assisted in situ keratomileusis 
[LASIK], photorefractive keratectomy, or any surgery 
involving a limbal or corneal incision) within 6 months prior to 
at Screening Visit
Patients who were currently using topical ocular medication or 
had used topical ocular medication within 2 weeks of 
Screening Visit; however, patients who were being treated 
bilaterally with the following could have been considered:
Current use of a marketed artificial tear, which was to 
have been discontinued at the Screening visit
Monotherapy for glaucoma or OHT using a prostaglandin 
analog, beta-blocker, alpha-2 agonist, or carbonic 
anhydrase inhibitors; any topical IOP-lowering 
to Screening Visit and the dosage was not expected to 
change during the study
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 

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Confidential Information
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
2.0
Abbreviations
AE
Adverse Event
PRN
As Needed
VAS
Visual Analog Scale
NA
Not Applicable
OTC
Over the Counter
PRO
Patient Reported Outcomes
OSDI
Ocular Surface Disease Index
PRK
Photorefractive Keratectomy
DED
Dry Eye Disease
IRB
Institutional Review Board
BID
Twice a Day
ICF
Informed Consent Form
AP
Analysis Population
OHT
Ocular Hypertension
IOP
Intraocular Pressure
NEI
National Eye Institute
LASIK
Laser-Assisted in Situ Keratomileusis
ICH
International Congress of Harmonization
GCP
Good Clinical Practice
GEP
Good Epidemiology Practice
CA
Competent Authority
EC
Ethics Committee
SAE
Serious Adverse Event
SOC
Standard of Care
PRO
Patient Reported Outcome
QoL
Quality of Life
SD
Standard Deviation
SEM
Standard Error of the Mean
EU
European Union
 

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3.0
Table of Contents
1.0
Synopsis ....................................................................................2
2.0
Abbreviations...........................................................................7
3.0
Table of Contents.....................................................................8
4.0
Background and Rationale...................................................11
4.1
Background..............................................................................................11
5.0
Research Question, Objectives and Endpoints...................12
5.1
Research Question ...................................................................................12
5.2
Study Objectives ......................................................................................12
5.2.1
Primary Objective ....................................................................................12
5.2.2
Secondary Objectives...............................................................................12
5.3
Study Endpoints.......................................................................................13
5.3.1
Primary Endpoint.....................................................................................13
5.3.2
Secondary Endpoints ...............................................................................13
5.3.3
Exploratory Endpoints .............................................................................13
6.0
Study Design...........................................................................13
6.1
Overall Design .........................................................................................13
6.2
Study Population......................................................................................15
6.2.1
Inclusion Criteria .....................................................................................16
6.2.2
Exclusion Criteria ....................................................................................17
6.3
Data Management ....................................................................................19
6.3.1
Data Source..............................................................................................19
6.3.2
Data Elements to Be Obtained.................................................................21
6.3.2.1
Prospective Data Component...................................................................21
6.3.3
Data Collection Methods .........................................................................21
6.4
Treatments................................................................................................22
6.4.1
Treatments Administered.........................................................................22
6.4.2
Storage and Disposition of Study Drug ...................................................23
6.4.3
Selection and Timing of Dose for Each Patient.......................................23
6.4.4
Study Drug Usage for Each Patient .........................................................24
6.4.5
Study Drug Accountability ......................................................................24
7.0
Statistical Methods, Sample Size and Analysis Plan..........25
 

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7.1
Analysis Populations................................................................................25
7.2
Sample Size and Justification ..................................................................25
7.3
Statistical Analysis Plan...........................................................................25
7.3.1
General Approach ....................................................................................25
7.3.2
Patients Demographics, Disease Characteristics, Treatment 
Patterns, and Treatment Discontinuation.................................................25
7.3.3
Primary Analysis......................................................................................26
7.3.4
Secondary Analysis..................................................................................26
7.3.5
Exploratory Analysis ...............................................................................26
8.0
Study Conduct .......................................................................27
8.1
Responsibilities Within the Study............................................................27
8.2
Protection of Human Subjects..................................................................27
8.3
Patient Information/Informed Consent ....................................................27
9.0
Safety Reporting ....................................................................27
9.1
Adverse Event Definition ........................................................................28
9.2
Serious Adverse Event Definition ...........................................................28
9.3
Serious and Nonserious Adverse Event Reporting..................................29
9.4
Patient Reported Outcomes and/or Quality of Life Questionnaires ........29
10.0
Pregnancy...............................................................................30
11.0
Product Complaint................................................................30
11.1
Definition .................................................................................................30
11.2
Complaint Reporting................................................................................31
12.0
Privacy and Confidentiality..................................................31
12.1
Data De-Identification..............................................................................31
12.2
Data Storage and Access..........................................................................32
12.3
Reports and Publications..........................................................................32
13.0
References...............................................................................32
14.0
Appendices .............................................................................32
List of Tables
Table 1.
Study Activities........................................................................................14
Table 2.
Identity of Investigational Product...........................................................23
 

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List of Figures
Figure 1.
Study Schematic.......................................................................................14
List of Appendices
Appendix A.
Study or Country Information Page.........................................................33
Appendix B.
Study Data Collection Forms...................................................................35
Appendix C.
Ocular Surface Disease Index (OSDI).....................................................37
Appendix D.
ABBV-444 Patient Eye Drop Experience Survey ...................................41
Appendix E.
Current Symptom Survey ........................................................................44
Appendix F.
AE/SAE Collection Form ........................................................................45
Appendix G.
Product Complaint Form..........................................................................49
 

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4.0
Background and Rationale
4.1
Background
Dry eye disease (DED) is a multifactorial disease of the ocular surface characterized by a 
loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear 
film instability and hyperosmolarity, ocular surface inflammation and damage, and 
neurosensory abnormalities play etiological roles (Craig 2017).
To date, management and treatment of DED remains a large unmet medical need. Current 
mainstays include use of artificial tears and in more severe cases, tear retention 
(temporarily or permanently plugging the tear ducts) and anti-inflammatory therapies 
(Craig 2017). Artificial tears have been used for relief for symptoms of eye dryness 
(burning, irritation, and discomfort) and have proven to be safe and effective for 
lubricating and protecting the ocular surface from further irritation and relieving eye 
dryness symptoms.
 
 
 
 
 
 
 
 
 
There is a gap in our knowledge as to the effect of ABBV-444 on patient symptom relief, 
product tolerability and the patient eye drop experience. ABBV-444 is developed to meet 
the requirements of section 505G of the Federal Food, Drug and Cosmetic (FD&C) Act, 
including the over-the-counter (OTC) drug monograph and other applicable requirements, 
therefore ABBV-444 can be brought to market in the US via the OTC drug monograph 
 

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process. The OTC drug monograph process does not require a manufacturer to submit 
clinical trial data demonstrating safety and effectiveness of an individual drug, nor does it 
require an OTC drug to be approved by FDA prior to marketing.
 
 
 
5.0
Research Question, Objectives and Endpoints
5.1
Research Question
There is no formal hypothesis as the nature of this study is to describe the effect of 
ABBV-444 on symptoms relief of dry eye, such as burning, irritation and, discomfort due 
to eye dryness, the onset of action of relief and the patient experience across various 
timepoints. 
 
 
5.2
Study Objectives
Evaluate the effect of ABBV-444 on symptom relief, product tolerability and the patient 
experience after product use over time in adult patients with dry eye (patients with 
symptoms of burning, irritation, discomfort due to eye dryness).
5.2.1
Primary Objective
The primary objective is to assess whether ABBV-444 will reduce patient symptoms 
when evaluated by OSDI questionnaire.
5.2.2
Secondary Objectives
The secondary objective is to investigate the patient eye drop experience of ABBV-444 
and the eye drop onset of action using a VAS-Current Symptom Survey.
 

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5.3
Study Endpoints
5.3.1
Primary Endpoint
The primary endpoint is the change from baseline in OSDI score at Day 30.
5.3.2
Secondary Endpoints
Patient Eye Drop Experience scores at Day 30
Change from baseline in symptom scores within 5 mins post administration of 
ABBV-444
5.3.3
Exploratory Endpoints
Patient Eye Drop Experience scores at Day 14
Change from baseline in of OSDI score at Day 14
6.0
Study Design
6.1
Overall Design
This prospective, minimally interventional study will aim to describe the effect of 
ABBV-444 on relieving dry eye symptoms, such as burning, irritation, discomfort due to 
eye dryness (via the OSDI scoring tool), the patient experience (via a Patient Eye Drop 
Experience Survey) and the onset of action of the eye drop (via the Current Symptom 
Survey) across various timepoints (Figure 1). This will be an open-label, 1-arm study in 
which eye drops will be administered bilaterally as needed but minimally twice a day. 
Approximately 40 patients are planned to be enrolled at 1 site. A screening period of up to 
6 days will be conducted prior to the Baseline Visit. Patients will be instructed to not 
administer any drops at least 4 hours prior to Baseline Visit. There will be three surveys 
administered to the subjects throughout the course of the study at the following 
timepoints: 
 
 
 
 
 

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1.
OSDI will be given at Screening Visit, Baseline, Day 14 and Day 30/Early exit; 
and 
2.
Patient Eye Drop Experience Survey at Day 14 and Day 30/Early exit; and 
3.
Current Symptom Survey at Day 1; T0 (pre-dosing), T30s, T1min, T3min and 
T5min post-dose.
4.
Study Product Usage Questionnaire at Day 14 and Day 30/Early exitStudy 
treatment is 30 days where OSDI scores, Patient Eye Drop Experience Survey 
scores and Current Symptom Survey scores will be obtained at the time points 
listed above. To assess product usage and compliance, the Study Product Usage 
Questionnaire will be administered at the time points listed above. Data will be 
collected via a paper questionnaire, sent to Lumanity where outcomes will be 
computed as mean changes from their baseline values.
Figure 1.
Study Schematic
Table 1.
Study Activities
It is recommended these procedures are completed in order listed at each study visit.
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Visit
Screening 
(Day 7)
Baseline 
(Day 1)
Day 14
Day 30/Early Exit
Visit Window
( 7 to 1 days)
(+/ 3 days)
(+/ 3 days)
Written informed consent
X
Urine pregnancy test (for 
females of childbearing potential 
only)
X
Demography
X
Adverse Event Assessment
X
X
X
X
Study Product Usage 
Questionnaire
X
X
OSDI Questionnaire
X
X
X
X
Biomicroscopy
X
X
Tear Breakup Time (with 
fluorescein)
X
Corneal staining (modified NEI 
grading scheme, with 
fluorescein)
X
X
Conjunctival staining (modified 
NEI grading scheme, with 
lissamine green)
X
X
Schirmer Test
X
Intraocular Pressure (Goldmann 
Applanation tonometer)a
X
X
ABBV-444 dispensed
X
X
Current Symptom Surveyb
X
Patient Eye Drop Experience 
Survey
X
X
Used and unused ABBV-444
returned
X
a.
For patients with primary open-angle glaucoma or ocular hypertension only
b.
Conducted at T0 (pre-dosing), T30 sec, T1min, T3 min and T5 min post-dose.
6.2
Study Population
The study population will consist of adult subjects with signs and symptoms of dry eye. 
The study will include 40 subjects with objective and subjective evidence of dry eye.
 

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6.2.1
Inclusion Criteria
Patients that meet the following eligibility criteria will be included:
Written informed consent and written documentation, in accordance with the 
relevant country and local privacy requirements, had been obtained prior to 
any study procedures
Had used artificial tears for dry eyes within the past year
Females of childbearing potential, with a negative pregnancy test result at 
Screening; these patients must have been currently using a reliable form of 
birth control and have agreed to use a reliable form of birth control for the 
duration of the study
Baseline Visits
Three consecutive tear break-
1 eye at Screening Visit
Grade 1 to 4 (modified National Eye Institute [NEI] Grid, score range = 0 to 5) 
staining in at least 1 area of the cornea (5 areas examined) or conjunctiva 
(6 areas examined) that was related to dry eye in at least 1 eye at both at 
Screening and Baseline Visits
Was able/agreed to continue to wear existing current spectacle correction 
during the study period (if applicable)
Currently corrected distance visual acuity of at least 20/32 Snellen equivalent 
in each eye using the 3-meter LogMar chart, with existing spectacle correction 
(if necessary) at Screening Visit
If using any form of topical ophthalmic cyclosporine (i.e., RESTASIS®), 
lifitegrast 5% ophthalmic solution (Xiidra®), participants must be using the 
o continue without 
change for the duration of the study
at Screening Visit for 
patients with primary open-angle glaucoma or ocular hypertension (OHT). 
Patients with primary open-angle glaucoma or OHT were included provided 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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in both eyes. Any topical IOP-lowering medications must have had a start date 
to change during the study.
Was able to follow study instructions and was likely to complete all required 
visits
6.2.2
Exclusion Criteria
Patients that have any of the following criteria will be excluded:
Have uncontrolled severe systemic disease that, in the assessment of the 
investigator, would put safety of the participant at risk through participation, or 
which would prevent or confound protocol-specified assessments 
(e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, 
systemic lupus erythematosus, immunodeficiency disease, etc.)
Known allergy or sensitivity to the study products or their components
Females who were pregnant, nursing, or planning a pregnancy
Females of childbearing potential and who were not using a reliable method of 
contraception
Current enrollment in an investigational drug or device study or participation 
in such a study within 30 days of entry into this study at Screening Visit
Patient anticipated contact lens wear during the study, or the patient had worn 
contact lenses in the last 3 months prior to Screening Visit
Any scheduled or planned elective ocular or systemic surgery or procedure 
during the study, which in the investigator's opinion, may have impacted the 
patient's study participation
At the Screening and Baseline visits, either eye has corneal staining score of 5 
in any of the 5 zones or a total score of > 19 based on the modified NEI 
grading scheme (score range = 0 to 5; graded in 5 zones of the cornea for a 
total score range of 0 to 25) or conjunctival staining score of 5 in any of the 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
  
 
 
 
 
 

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6 zones based on the modified NEI grading scheme (score range = 0 to 5 per 
zone)
Use of systemic medications (over-the-counter, herbal, prescription, or 
nutritional supplements for dry eyes), which may have affected tear film or 
vision (including but not limited to the following: flax seed oil, fish oil, 
omega-3 supplements, cyclosporine, antihistamines, cholinergic agents, 
anticholinergics, antimuscarines, beta-blocking agents, tricyclic 
antidepressants, phenothiazines, estrogen-progesterone, and other estrogen 
derivatives), unless that medication had been used at the same dose for at least 
3 months prior to screening and the dosage was not expected to change during 
the course of the study
Presence of 1 or more of the following ocular conditions in at least 1 eye:
Active ocular infection or non-keratoconjunctivitis sicca (KCS) ocular 
inflammation
Active ocular allergy
History of recurrent herpes keratitis or active disease within 6 months prior to 
Screening Visit
Corneal disorder or abnormality that affected corneal sensitivity or normal 
spreading of the tear film (except superficial punctate keratitis)
Severe blepharitis or obvious inflammation of the lid margin, which in the 
judgment of the investigator, may have interfered with the interpretation of the 
study results
Keratoconjunctivitis sicca secondary to the destruction of conjunctival goblet 
cells, such as occurs with vitamin A deficiency or scarring such as that with 
cicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or 
irradiation
Substantial non-KCS keratitis with overlying corneal stain or other significant 
corneal findings not directly related to dry eye; in addition, patients with dry 
eye signs/symptoms (e.g., filamentary keratitis) of a severity where topical 
monotherapy with an artificial tear would have been inappropriate
Occlusion of the lacrimal puncta for either eye, with punctal plugs or 
cauterization < 3 months prior to Screening Visit
 
 
 
 
 
 
 
 
 
 
 

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History of prior ocular/ophthalmic surgery or trauma, which could affect 
corneal sensitivity and/or tear distribution (e.g., cataract surgery, laser-assisted 
in situ keratomileusis [LASIK], photorefractive keratectomy, or any surgery 
involving a limbal or corneal incision) within 6 months prior to at Screening 
Visit
Patients who were currently using topical ocular medication or had used 
topical ocular medication within 2 weeks of Screening Visit; however, patients 
who were being treated bilaterally with the following could have been 
considered:
Current use of a marketed artificial tear, which was to have been 
discontinued at the Screening Visit
Monotherapy for glaucoma or OHT using a prostaglandin analog, beta-
blocker, alpha-2 agonist, or carbonic anhydrase inhibitors; any topical 
IOP-
Screening Visit and the dosage was not expected to change during the 
study
If using any form of topical ophthalmic cyclosporine (i.e., RESTASIS®), 
lifitegrast 5% ophthalmic solution (Xiidra®), for less than 90 days prior to 
Screening Visit
Patients who were currently being treated with both IOP-lowering medication 
and any form of topical ophthalmic cyclosporine (i.e., RESTASIS®) or 
lifitegrast 5% ophthalmic solution (Xiidra®) or generic of these medications 
cannot be enrolled
Patient had a condition or is in a situation, which in the investigator's opinion, 
may have put the patient at significant risk, may have confounded the study 
results, or may have interfered significantly with the patient's participation in 
the study
6.3
Data Management
6.3.1
Data Source
OSDI is a validated PRO tool which consists of 12-item questionnaire 
evaluating a patient's dry eye symptom severity using a 6-point scale. All 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
  
 
 
 
 

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participants will complete an OSDI Questionnaire. The purpose of this 
assessment is to capture a range of ocular surface symptoms, including 
symptoms related to dry eye, their severity, and their impact on the 
participant's ability to function, scaled into a 0 (no disease) to 100 (maximum 
severity of disease) score. Participants will complete the OSDI at Screening 
Visit, Baseline Visit, Day 14 and Day 30/Early exit.
Patient Eye Drop Experience Survey will evaluate the short- and long-term 
subjective eye drop experience in relief and tolerability with the study eye 
drops using a VAS. All participants will complete the Patient Eye Drop 
Experience Survey Day 14 and Day 30/Early exit. Participants should be 
instructed to mark a vertical line on the anchored VAS that best describes their 
agreement with the statements within the questionnaire. The vendor Lumanity 
will then convert the participant's response to a numerical value (0 to 100). 
This is an overall evaluation, not per eye.
Current Symptom Survey will evaluate the subjective onset of action of the 
eye drop as it pertains to relief and tolerability using a VAS. All participants 
will complete the Current Symptom Survey at Day 1. Survey will be 
administered at T0 (pre-dosing), T30s, T1min, T3min and T5min post-dosing. 
Participants should be instructed to mark a vertical line on the anchored VAS 
that best describes their agreement with the statements within the 
questionnaire. The vendor Lumanity will convert the participant's response to a 
numerical value (0 to 100). This is an overall evaluation, not per eye. Study 
Product Usage Questionnaire will evaluate the product usage and compliance 
of study drug. All participants will complete the Study Product Usage 
Questionnaire at Day 14 and Day 30/Early exit. The vendor Lumanity will 
collect the data.
 
 

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6.3.2
Data Elements to Be Obtained
6.3.2.1
Prospective Data Component
OSDI
The OSDI will be administered to patients at Screening Visit, Baseline Visit, Day 14 and 
Day 30/Early exitpost-ABBV-444 administration. The OSDI can be found in Appendix C.
Patient Eye Drop Experience Survey
The Patient Eye Drop Experience Survey will be administered to patients at Day 14 and 
Day 30/Early exit, post ABBV-444 administration. The Patient Experience Survey can be 
found in Appendix D.
Current Symptom Survey
Current Symptom Survey will be administered to patients on Day 1; T0 (pre-dosing), 
T30s, T1min, T3min and T5 min post-dose at the study site. The Current Symptom 
Survey can be found in Appendix E.
Study Product Usage Questionnaire 
Study Product Usage Questionnaire will be administered to patients at Day 14 and 
Day 30/Early exit. The Study Product Usage Questionnaire answers will be recorded in 
the Data Collection Forms, Appendix B.
6.3.3
Data Collection Methods
Eligible participants will be provided an IRB approved ICF. The physician or their staff 
will record any relevant patient information per standard of care (SOC) into their local 
patient health record keeping system. Patient eligibility, required demographics and 
additional visit information will be recorded in supplied paper study data forms 
(Appendix B). In addition, any applicable safety reporting will be recorded on the 
 

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supplied paper AE/SAE forms (Appendix F) and follow the process outlined in 
Section 9.3.
Paper English versions of the OSDI, Current Symptom Survey, Patient Eye Drop 
Experience Survey and the Study Product Usage Questionnaire will be provided to the site 
and labeled with a unique patient number for completion by the patient. Consented 
patients who meet all inclusion and none of the exclusion criteria will be allowed to 
complete these questionnaires at the specified study days. The participating site will be 
asked to send the completed questionnaires regularly to Lumanity (see Appendix A).
6.4
Treatments
6.4.1
Treatments Administered
During the treatment phase, each patient will be instructed to instill 1 to 2 drops of 
ABBV-444 in each eye, as needed, but at least 2 times daily. The same vial can be used 
for both eyes and should be used one time only. The used vial should then be stored in the 
supplied collection bag and returned to the site at the next scheduled visit for drug 
accountability, Section 6.4.5.
Patients are to be instructed during Screening Visit to not use any eye drops (artificial 
tears or prescription) for at least 4 hours prior to their Baseline Visit. If the patient is 
concurrently using allowed RESTASIS or IOP-lowering therapy drops during the study
treatment they are to be instructed to wait a minimum of 15 minutes between 
administration of study drug and the allowed concomitant eye drops.
 

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6.4.4
Study Drug Usage for Each Patient
The 2-question Study Eye Drop Usage Questionnaire will be completed by each patient at 
Day 14 and Day 30/Early exit to capture the date and time of their last study drug 
administration and their overall compliance to study drug usage.
Question 1: "What date and time did you last use your study eye drops?"
Question 2: "On average, how many times did you administer the eye drops per day?"
Sites should review each patient's response to ensure that the last administration of their 
using their study eye drops at minimum 2 times per day. Should either of the patient's 
responses be out of compliance, the site should discuss with the patient to ensure they 
dose correctly from that point forward.
6.4.5
Study Drug Accountability
The investigator or his representative will verify that study drug supplies are received
intact and in the correct amounts. This will be documented by signing and dating the
Proof of Receipt or similar document. The investigator or his designated representatives
will dispense study drug only to patients enrolled in the study. A current (running) and
accurate inventory of study drug will be kept by the investigator and will include shipping
invoices and the date on which study drug is allocated to patients, as well as used and 
unused study drug returned by patients. An overall accountability of the study drug will 
be performed and verified by the investigator or his representative throughout the study
until its completion. Upon completion or termination of the study, all original containers 
(containing used and unused study drug) will be destroyed on site per instructions 
supplied by AbbVie. All study drug accountability logs will be sent to Lumanity, per 
contact information found in Appendix A.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7.0
Statistical Methods, Sample Size and Analysis Plan
Analysis of all data will be descriptive. Biometrical analysis will be conducted based on 
subject demographics. Arithmetic mean, median, standard deviation (SD), standard error 
of the mean (SEM), interquartiles, minimum, and maximum will be used for the 
description of the data. Descriptive p-values (paired t-test) will be calculated for changes 
during the observation period, if adequate.
7.1
Analysis Populations
The full analysis set (FAS) will consist of all subjects who are study eligible based on the 
inclusion and exclusion criteria and complete 30 days of treatment for this study.
7.2
Sample Size and Justification
This study is not a confirmatory study with hypothesis testing. At least 40 subjects will be 
enrolled in this study based on a feasibility assessment. Assuming a non-response rate of 
10% at Day 30, there would be about 36 evaluable subjects.
7.3
Statistical Analysis Plan
7.3.1
General Approach
Demographic and other baseline subject characteristics will be summarized. Descriptive 
statistics (such as mean, standard deviation, median, minimum and maximum) will be 
presented for each continuous variable. Categorical variables will be displayed using 
frequency counts and percentages.Patients Demographics, Disease 
Characteristics, Treatment Patterns, and Treatment Discontinuation
Demographics and other baseline characteristics of the study subjects will be summarized 
descriptive statistics (such as mean, median, standard deviation, median, standard error of 
the mean (SEM) interquartiles, min and max) will be presented for each continuous 
variable, Categorical variables will displayed using frequency counts with percentages.
 

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7.3.3
Primary Analysis
The analysis is based on full analysis set (FAS). The primary endpoint is the change of 
OSDI score from baseline at Day 30. The change of OSDI score will be summarized 
using descriptive statistics: mean, median, standard deviation, standard error of the mean 
(SEM), interquartiles, min and max. A descriptive p-value (paired t-test) will be 
calculated for the change of OSDI score if the data is adequate.
7.3.4
Secondary Analysis
The secondary endpoints of interest are the Patient Eye Drop Experience Survey score at 
Day 30 and the change of Current Symptom Survey score from baseline at T5min post-
dose. The score of each item in the Patient Eye Drop Experience Survey at Day 30 and the 
change of Current Symptom Survey at T5min will be summarized using descriptive 
statistics: mean, median, standard deviation, standard error of the mean (SEM), 
interquartiles, min and max. In the meanwhile, one bar plot for the mean of the score with 
95% confidence interval will be made for each of the secondary endpoints. The change of 
Current Symptom Survey score from baseline at T5min will be summarized using the 
same descriptive statistics. A descriptive p-value (paired t-test) will be calculated for the 
change of VAS score if the data is adequate.
7.3.5
Exploratory Analysis
The exploratory endpoints of interest are the Patient Eye Drop Experience Survey score at 
Day 14 and the change of OSDI score from baseline at Day 14. The score of each item in 
the Patient Eye Drop Experience Survey at Day 14 and the change of OSDI score from 
baseline at Day 14 will be summarized using descriptive statistics: mean, median, 
standard deviation, standard error of the mean (SEM), interquartiles, min and max. In the 
meanwhile, one bar plot for the mean of the score with 95% confidence interval will be 
made for each of the exploratory endpoints. The change of OSDI from baseline at Day 14 
will be summarized using the same descriptive statistics. A descriptive p-value (paired 
t-test) will be calculated for the change of VAS score if the data is adequate.
 

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8.0
Study Conduct
8.1
Responsibilities Within the Study
The study will be conducted by the Investigator and Lumanity under AbbVie oversight. 
The study shall be conducted as described in the approved protocol.
8.2
Protection of Human Subjects
The study will be conducted in accordance with ethical principles that have their origin in 
the current Declaration of Helsinki and will follow the principles of International 
Conference Harmonization Good Clinical Practice (ICH GCP) and Good Epidemiology 
Practice (GEP) and applicable regulatory requirements. IRB/EC notification or approval 
will be obtained prior to the initiation of the study as necessary per local Regulation.
8.3
Patient Information/Informed Consent
This study will be run in compliance with local laws and regulations. 
Notification/submission to the responsible Ethics Committee, and/or Competent 
Authorities will be performed as required by local laws and regulations (see Country 
Information page [Appendix A]).
Written informed consent will be obtained prior to patient inclusion.
9.0
Safety Reporting
Please notify AbbVie of any adverse event whether serious or nonserious and record the 
information in the provided AE/SAE Data Collection Form (Appendix F).
The AbbVie contact details are specified in Country Information page (Appendix A).
The following adverse event and safety information definitions and further information is 
provided should you need to report any safety information to AbbVie.
 

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9.1
Adverse Event Definition
An AE is defined as any untoward medical occurrence in a patient or clinical investigation 
patient administered a pharmaceutical product and which does not necessarily have a 
causal relationship with this treatment. An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease 
temporally associated with the use of a medicinal product, whether or not the event is 
considered causally related to the use of the product.
Such an event can result from use of the drug as stipulated in the protocol or labeling, as 
well as from "special situations" as accidental or intentional overdose, medication error, 
occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug 
withdrawal, all which must be reported whether associated with an adverse event or not. 
Any worsening of a pre-existing condition or illness is considered an AE and should be 
reported as a new AE.
9.2
Serious Adverse Event Definition
If an adverse event meets any of the following criteria, it is considered a serious adverse 
event (SAE):
Death of Patient
An event that results in the death of a patient.
Life-Threatening
An event that, in the opinion of the treating physician, would 
have resulted in immediate fatality if medical intervention 
had not been taken. This does not include an event that 
would have been fatal if it had occurred in a more severe 
form.
Hospitalization or 
Prolongation of 
Hospitalization
An event that results in an admission to the hospital for any 
length of time or prolongs the patient's hospital stay. This 
does not include an emergency room visit or admission to an 
outpatient facility.
Congenital Anomaly
An anomaly detected at or after birth or any anomaly that 
result in fetal loss.
 

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Persistent or 
Significant 
Disability/Incapacity
An event that results in a condition that substantially 
interferes with the activities of daily living of a patient. 
Disability is not intended to include experiences of relatively 
minor medical significance such as headache, nausea, 
vomiting, diarrhea, influenza, and accidental trauma (e.g., 
sprained ankle).
Important Medical 
Event Requiring 
Medical or Surgical 
Intervention to 
Prevent Serious 
Outcome
An important medical event that may not be immediately 
life-threatening or result in death or hospitalization, but 
based on medical judgment may jeopardize the patient and 
may require medical or surgical intervention to prevent any 
of the outcomes listed above (i.e., death of patient, life 
threatening, hospitalization, prolongation of hospitalization, 
congenital anomaly, or persistent or significant 
disability/incapacity). Additionally, any elective or 
spontaneous abortion or stillbirth is considered an important 
medical event. Examples of such events include allergic 
bronchospasm requiring intensive treatment in an emergency 
room or at home, blood dyscrasias or convulsions that do not 
result in inpatient hospitalization, or the development of drug 
dependency or drug abuse.
9.3
Serious and Nonserious Adverse Event Reporting
For serious adverse events from patients using an AbbVie product notify 
AbbVie within 24 hours of the physician becoming aware of the event.
For nonserious adverse events from patients using an AbbVie product 
notify AbbVie within 15 calendar days of the physician becoming aware of the 
event, including "special situations."
AbbVie contact details are specified in the Country Information page (Appendix A).
9.4
Patient Reported Outcomes and/or Quality of Life 
Questionnaires
Patient Reported Outcome (PRO) or Quality of Life (QoL) questionnaires data are not 
considered a potential source of adverse events for the purposes of this study. However, 
 
 
 

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the physician should review the PRO or questionnaire(s) data. If the physician identifies 
an adverse event and it is determined to be related to an AbbVie authorized product, 
report to AbbVie as described above and to the relevant Regulatory Authority, as required 
by local laws and regulations.
10.0
Pregnancy
If at any time you need to report a pregnancy occurrence in a patient taking an AbbVie 
product, the physician can notify AbbVie using the contact details in Appendix A within 
24 hours of the physician becoming aware of the pregnancy.
Pregnancy is not considered an adverse event. The medical outcome for either mother or 
infant, meeting any serious criteria including an elective or spontaneous abortion, is 
considered a serious adverse event and must be reported to AbbVie using the details in 
Appendix A within 24 hours of the site becoming aware of the event and to the relevant 
Regulatory Authority, as required by local laws and regulations.
11.0
Product Complaint
Product complaints will be collected as part of this study; if at any time you need to report 
a Product Complaint (Appendix G) please refer to this section for the definition and 
reporting requirements.
11.1
Definition
A Product Complaint is any Complaint related to the biologic or drug component of the 
product or to the medical device component(s).
For a product this may include, but is not limited to, damaged/broken product or 
packaging, product appearance whose color/markings do not match the labeling, labeling 
discrepancies/inadequacies in the labeling/instructions (example: printing illegible), 
missing components/product, device not working properly, or packaging issues.
 

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For medical devices, a product complaint also includes all deaths of a patient using the 
device, any illness, injury, or adverse event in the proximity of the device, an adverse 
event that could be a result of using the device, any event needing medical or surgical 
intervention including hospitalization while using the device and use errors.
Any information available to help in the determination of causality by the device to the 
events outlined directly above should be reported.
11.2
Complaint Reporting
Product complaints concerning an AbbVie authorized product must be reported to AbbVie 
within 24 hours of the site's knowledge of the event using the contact details in 
Appendix A. All follow-up information is to be reported to the Sponsor (or an authorized 
representative) and documented in source as required by the Sponsor. All complaints will 
be monitored on an ongoing basis.
Product Complaints may require return of the product with the alleged complaint 
condition (syringe, pen, etc.). In instances where a return is requested, every effort should 
be made by the physician to return the product within 30 days. If returns cannot be 
accommodated within 30 days, the site will need to provide justification and an estimated 
date of return.
The description of the complaint is important for AbbVie in order to enable AbbVie to 
investigate and determine if any corrective actions are required.
12.0
Privacy and Confidentiality
12.1
Data De-Identification
Before Personal Data is shared with AbbVie, the institution/doctor and his/her staff must 
replace any information that could directly identify a patient (such as name, address, and 
contact information) with a generic code which AbbVie cannot link to patient identity. 
Personal Data with identifying information may not be shared.
 

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12.2
Data Storage and Access
AbbVie will store study data and any Coded Data it receives in a limited-access, secure 
storage space. AbbVie may retain the study data and any Coded Data reported to it for as 
long as AbbVie is conducting medical research in the therapeutic area that is the subject 
of this research or as long as the marketed product related to this research project is used, 
or longer, if required by EU or local laws and regulations governing research activities.
12.3
Reports and Publications
At the end of the study, a report or publication will be written by AbbVie. This 
report/publication will contain a description of the objectives of the study, the 
methodology and its results and conclusions. The completed questionnaires and the final 
study output are the confidential property of AbbVie and may not be released to 
unauthorized people in any form (publications or presentations) without the express 
written approval from AbbVie.
13.0
References
1.
Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Executive Summary. Ocul 
Surf. 2017;15:575-628.
2.
Miller KL, Walt JG, Mink DR, et al. Minimal clinically important difference for 
the ocular surface disease index. Arch Ophthalmol. 2010;128(1):94-101.
14.0
Appendices
 

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Appendix A.
Study or Country Information Page
A Patient Experience Study with ABBV-444 for Symptom Relief and Tolerability
Name of Medical Director:
 PhD
Address: 2525 Dupont Drive, Irvine, CA, 92612
Country: United States
Phone:
Email:
Safety/Pregnancy Reporting to:
E-mail: IR-Clinical-SAE@abbvie.com
Fax:
Back-up fax number:
Complaints Reporting to:
E-mail: Productqualitycomplaints@abbvie.com
Shipment address for Study Data Forms /Questionnaires:
Name: Lumanity
Address: 200 Pine Ave, Suite 200, Long Beach, CA 90802
Country: USA
Phone:
Fax:
 

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Requirements per Local Regulations:
Competent Authority approval
Competent Authority notification
Competent Authority involvement not required
Ethics Committee approval
Ethics Committee notification
Ethics Committee involvement not required
Written Patient Informed Consent required:
No*
Yes
*Provide a reason___________________________________________________
Regulatory requirements, other (if applicable):
Name of Affiliate Medical Director or equivalent role (i.e., Regulatory for US)
Signature
Date
 

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Appendix B.
Study Data Collection Forms
Date (MM/DD/YYYY): ___________________________________
Patient Identification Number: _____________________________
Eligibility 
Did the patient meet all the Inclusion Criteria in Protocol Section 6.2.1?  
Yes 
No
If "No", which criteria were not met:
Did the patient meet any Exclusion Criteria in Protocol Section 6.2.2?
Yes 
No
If "No", which criteria were met: ___________________________
Patient Demographics
Age:  _
__________________
Sex:  
Female
Male
Race:
American Indian or Alaska Native
Asian
Black or African American
White 
Other
Ethnicity:
Hispanic or Latino
Not Hispanic or Latino
Study Visits
Screening Date: (MM/DD/YYYY): 
Baseline/Day 1: (MM/DD/YYYY): 
1. If applicable, did you use your RESTASIS or IOP-lowering therapy drops in 
the past 4 hours? 
Yes 
No
NA
Day 14: (MM/DD/YYYY): 
2. What date and time did you last use your study eye drops? ___________
3. On average, how many times did you administer the eye drops per 
day?
___________
 

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Day 30: (MM/DD/YYYY): 
1. What date and time did you last use your study eye drops? ___________
2. On average, how many times did you administer the eye drops per 
day?
___________
Safety
Were there any AE/SAEs Reported?
Yes 
No
If "Yes", complete appropriate form(s) in Appendix F.
Principle Investigator
Date
 

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Appendix C.
Ocular Surface Disease Index (OSDI)
Ocular Surface Disease Index© (OSDI©)2
Ask your patient the following 12 questions, and circle the number in the box that best 
represents each answer. Then, fill in boxes A, B, C, D, and E according to the instructions 
beside each.
HAVE YOU EXPERIENCED ANY OF THE FOLLOWING DURING THE LAST WEEK :
HAVE PROBLEMS WITH YOUR EYES LIMITED YOU
IN PERFORMING ANY OF THE FOLLOWING DURING THE LAST WEEK :
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 

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HAVE YOUR EYES FELT UNCOMFORTABLE
IN ANY OF THE FOLLOWING SITUATIONS DURING THE LAST WEEK :
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix G.
Product Complaint Form
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Title
A Patient Experience Study with ABBV-444 for Symptom Relief 
and Tolerability
Date of Version of 
Protocol
02 February 2023
Approved by:
Protocol Author 
Date
Scientific Director 
 
Date