Clinical trial NCT03499873
Conditions: Cataract
Sponsor: Actavis Inc.
Start date: 2018-03-28; Completion date: 2018-12-18
Enrollment: 448 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract surgery.

Detailed description:

Arms: arm 1: Test product manufactured by Indoco Remedies, Ltd for Actavis LLC. arm 2: Reference product manufactured by Alcon Laboratories Inc. arm 3: Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
Interventions: intervention 1: Nepafenac 0.3% Oph Susp intervention 2: Placebos intervention 3: Nepafenac 0.3% Oph Susp (reference)
Intervention descriptions: intervention 1: Nepafenac 0.3% Ophthalmic suspension (experimental product) intervention 2: Placebo intervention 3: Nepafenac 0.3% Ophthalmic suspension (Innovator)

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 


Statistical Analysis Plan  
 
Version Final  
Date Sep11, 2018 
2 
TABLE OF CONTENTS 
PAGE 
TITLE PAGE ............................................................................................................................ 1 
TABLE OF CONTENTS ......................................................................................................... 2 
LIST OF ABBREVIATIONS .................................................................................................. 4 
1. 
INTRODUCTION ................................................................................................... 5 
2. 
OBJECTIVES .......................................................................................................... 5 
3. 
STUDY OVERVIEW .............................................................................................. 5 
3.1 
Study Design ............................................................................................................ 5 
3.2 
Sample Size .............................................................................................................. 6 
3.3 
Randomization Procedures ...................................................................................... 7 
4. 
STUDY ENDPOINTS/OUTCOMES ...................................................................... 7 
5. 
HYPOTHESES TESTING ...................................................................................... 7 
6. 
ANALYSIS SUBSETS ............................................................................................ 8 
6.1 
Safety Population ..................................................................................................... 8 
6.2 
Modified Intent to Treat Population (mITT Population) ......................................... 8 
6.3 
Per Protocol Population (PP Population) ................................................................. 8 
7. 
STATISTICAL METHODS OF ANALYSIS ......................................................... 9 
7.1 
General Principles .................................................................................................... 9 
7.1.1 
First Dose of the Study Drug ................................................................................. 10 
7.2 
Subject Disposition ................................................................................................ 10 
7.3 
Demographic and Baseline Characteristics............................................................ 11 
7.4 
Medical History ..................................................................................................... 12 
7.5 
Protocol Deviations ................................................................................................ 12 
7.6 
Cataract Surgery ..................................................................................................... 12 
7.7 
Efficacy Analyses .................................................................................................. 12 
7.7.1 
Analyses of Primary Endpoint ............................................................................... 12 
7.7.2 
Analyses of Individual Efficacy Parameters .......................................................... 13 
7.8 
Safety Analyses ...................................................................................................... 14 
7.8.1 
Adverse Events ...................................................................................................... 14 
7.8.2 
Laboratory Tests .................................................................................................... 15 
7.8.3 
Vital Signs .............................................................................................................. 16 
7.8.4 
Physical Examination ............................................................................................. 16 


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7.8.5 
Visual Acuity ......................................................................................................... 16 
7.8.6 
Slit Lamp Examination .......................................................................................... 16 
7.8.7 
Intraocular Pressure ............................................................................................... 17 
7.8.8 
Dilated Fundus Examination .................................................................................. 17 
7.8.9 
Exposure to Product ............................................................................................... 17 
7.8.10 
Exposure to Concomitant Medication ................................................................... 18 
7.8.11 
Other assessments .................................................................................................. 18 
8. 
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES ............................... 18 
9. 
LIST OF PLANNED TABLES, FIGURES, AND LISTINGS ............................. 19 
10. 
LITERATURE CITATIONS / REFERENCES ..................................................... 19 
11. 
APPENDICES ....................................................................................................... 20 
11.1 
Study visit Schedule ............................................................................................... 20 
11.2 
Aqueous Cells Scale .............................................................................................. 21 
11.3 
Aqueous Flare Scale .............................................................................................. 21 
11.4 
Ocular Pain Scale ................................................................................................... 22 
11.5 
Code Fragments ..................................................................................................... 22 
 


Statistical Analysis Plan  
 
Version Final  
Date Sep11, 2018 
4 
LIST OF ABBREVIATIONS 
Abbreviation or 
special term 
Explanation 
AE 
Adverse Event 
BMI 
Body Mass Index 
CRO 
Clinical Research Organization 
DOB 
Date of Birth 
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
HEENT 
Head, Eyes, Ears, Nose, Throat 
IOP 
Intraocular Pressure 
IP 
Investigational Product 
IWRS 
Interactive Web Response System 
LOCF  
Last Observation Carried Forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified Intent to Treat 
PP 
Per Protocol 
PT 
Preferred Term 
TEAE 
Treatment Emergent Adverse Event 
SAE 
Serious Adverse Event 
SOC 
System Organ Class 
 


Statistical Analysis Plan  
 
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Date Sep11, 2018 
5 
1. 
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to provide details of the statistical 
analyses that have been outlined within the protocol "A randomized, multicenter, double 
masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical 
equivalence and safety of Nepafenac 0.3% ophthalmic suspension 
 
 Actavis LLC) with Ilevro™ (Nepafenac ophthalmic suspension), 0.3% of 
Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract 
surgery", version 2.0, amendment 2.0 dated June 25, 2018. 
This study is designed to determine clinical equivalence of an ophthalmic suspension in order 
to facilitate the registration of a generic version of Nepafenac 0.3% suspension. The reference 
listed drug for this suspension is Ilevro™ (Nepafenac Ophthalmic Suspension 0.3%). This 
study will be conducted in male and female subjects with cataract. 
This document will give a description of the planned methods of the analysis. 
2. 
OBJECTIVES 
The objectives of this study are: 
• To demonstrate the clinical equivalence of Nepafenac 0.3 % ophthalmic suspension 
(
 Actavis LLC) with Ilevro™ (Nepafenac 
ophthalmic suspension), 0.3 % of Alcon Laboratories, Inc. for the treatment of pain 
and inflammation associated with cataract surgery. 
• To demonstrate the superiority of the efficacy of the test and reference products over 
the placebo control in the treatment of pain and inflammation associated with cataract 
surgery.  
3. 
STUDY OVERVIEW 
3.1 
Study Design 
Approximately 450 subjects 
 
will be enrolled and randomized in this investigational study.
 
 
One drop of the suspension should be instilled into the affected eye one-time daily, beginning 
a day prior to the planned cataract surgery, on the day of the cataract surgery, and for 14 days 
thereafter. On the day of cataract surgery (day 0) a drop should be added 30-120 minutes prior 
to the surgery and an additional drop will be administered following cataract surgery prior to 
the subject leaving the surgery center. The study is designed to be only monocular (only one 
eye per subject).  


Statistical Analysis Plan  
 
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Date Sep11, 2018 
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The dose and mode of treatment chosen in this study is the dosage approved by US FDA for 
the treatment of pain and inflammation associated with cataract surgery. 
The study subjects will undergo clinical evaluations throughout the study in order to assess 
efficacy and safety at the following visits: 
• Visit 1:  Day -21 to Day -1 (Screening/Baseline/Randomization Visit)  
• Visit 2: Day 0 (The Day of Cataract Surgery) 
• Visit 3: Day 1 (One Day After the Cataract Surgery)  
• Visit 4: Day 7± 2 Days (Follow up Visit)  
• Visit 5: Day 14 ±2 Days (End of Study Visit/Early Discontinuation) 
An Unscheduled Visit is allowed at any time, for any reason, if in the Investigator’s opinion it 
is warranted.  
If the Investigator determines that the study subject’s condition has worsened to the degree 
that it is unsafe for continuation in the study, the study subject may be discontinued and will 
be evaluated as a treatment failure. 
3.2 
Sample Size  
 
 
 
 
 
 
 
 
 
 
 
 
Thus, approximately 450 subjects 
 
 will be enrolled and randomized
 
 
 
 


Statistical Analysis Plan  
 
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3.3 
Randomization Procedures  
Subjects will be randomly assigned 
 to receive the Test 
product or the Reference Product or the Placebo control, respectively. The randomization 
schedule for this study will be generated by a third-party vendor of the CRO such that a non-
study-assigned independent expert will allocate the subjects to one of the three treatment arms 
using a computer generated automated process i.e. Interactive Web Response System (IWRS). 
A sealed copy of the randomization scheme  will be retained at the study site and should be 
available to regulatory authority inspectors at the time of site inspection to allow for 
verification of the treatment identity of each subject. 
4. 
STUDY ENDPOINTS/OUTCOMES 
Primary Efficacy Endpoint 
The primary efficacy endpoint is the proportion of subjects with cure at Day 14 defined as a 
score of 0 for aqueous cells, a score of 0 for aqueous flare and a score of no more than 3 for 
pain.  
Safety Endpoints 
The safety endpoints include: 
• The incidence of treatment emergent adverse events.  
• Ocular parameters (visual acuity, intraocular pressure measurement, slit lamp 
evaluation and dilated fundus examination). 
5. 
HYPOTHESES TESTING 
Hypothesis of Equivalence 
A two-sided, continuity-corrected, 90% confidence interval on the Test-to-Reference 
difference for the proportion of subjects with cure will be constructed.  
Bioequivalence will be established if the 90% confidence interval for the difference is 
contained within the interval [-0.20, +0.20]. 
Hypothesis of Superiority 
The null hypothesis to be tested is that there is no difference in the proportions of subjects 
with cure.  The evaluation of superiority will be conducted separately for the Test treatment 
versus the Placebo treatment and for the Reference treatment versus the Placebo treatment.  
The analysis will be conducted using two-sided, α = 0.05, Fisher’s exact test.  


Statistical Analysis Plan  
 
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Date Sep11, 2018 
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Superiority will be established if the proportion of cure for each active treatment is greater 
than, and statistically different from, that of the Placebo. 
6. 
ANALYSIS SUBSETS 
6.1 
Safety Population 
The safety population includes any subject who was randomized into the study and has 
evidence of usage of at least one dose of IP according to subject's diary or eCRF. 
6.2 
Modified Intent to Treat Population (mITT Population) 
The mITT population includes all randomized subjects who met all inclusion/exclusion 
criteria and return for at least one post-operative evaluation visit.  This population will be used 
while testing the superiority. 
6.3 
Per Protocol Population (PP Population) 
The PP population includes all randomized subjects who: 
• Met all the inclusion and none of the exclusion criteria;  
• 
 
 
 
  
 
 
 
  
  
 
 
  
 
 
 
 


Statistical Analysis Plan  
 
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For the purpose of determining the PP status of the subject, a "protocol deviations that would 
affect the treatment evaluation" is any of the major protocol deviations as defined in section 
7.5. 
The PP population will be used for testing the clinical equivalence. 
7. 
STATISTICAL METHODS OF ANALYSIS 
7.1 
General Principles 
The statistical analyses will be performed by 
 under the direction of the 
Sponsor, Actavis LLC, using SAS Version 9.4 (or higher). All tables, figures, and listings will 
be produced in the landscape format.  
In general, all data will be listed by treatment group, subject and visit/time point where 
appropriate.  The summary tables will also be stratified by, or have columns corresponding to, 
treatment groups. 
All subjects will be identified by their unique subject numbers. 
The total number of subjects in the study group (N) under the stated population will be 
displayed in the header of summary tables. 
Data will be summarized using descriptive statistics for continuous variables.  Unless 
otherwise specified, descriptive statistics will include number of subjects, mean, standard 
deviation, minimum, median, and maximum.  The minimum and maximum statistics will be 
presented to the same number of decimal places as the original data.  The mean and median 
will be presented to one more decimal place than the original data.  The standard deviation 
will be presented to two more decimal places than the original data.  The number of missing 
observations will be presented only if non-zero. 
In summary tables of categorical variables, counts, and percentages will be used.  The count 
[n] indicates the actual number of subjects in a particular category, which should always be 
less than or equal to the total number of subjects in the respective study group with known 
(non-missing) category [M].  Percentage will be obtained by: % = n/M*100.  Unless otherwise 
stated, all percentages will be expressed to one decimal place. 
All statistical tests will be two-sided at a significance level of α = 0.05, unless otherwise 
indicated.  No adjustment will be made for multiplicity. 
The eye on which the cataract surgery is performed will be referred to as the study eye, and 
the other eye as the non-study eye. Ocular safety information will be presented separately for 
the study eye and non-study eye. Efficacy will be assessed for the study eye only. 
Baseline will be defined as the last assessment obtained prior to the first dose of the study 
drug, unless otherwise specified. 


Statistical Analysis Plan  
 
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Relative days will be calculated relative to date of first dose of study medication.  Relative 
days will be calculated as follows only when the full assessment date is known (i.e., partial 
dates will have missing relative days). 
For assessment on or after the day of first dose of study drug: 
Relative Day = Date of Assessment – Date of First Dose of study Drug+1. 
For assessment before the day of first dose of study drug: 
Relative Day = Date of Assessment – Date of First Dose of study Drug. 
Note: relative days are different from protocol-specified visit names; Day -1 visit will 
typically correspond to Day 1 relative to the first dose of the study drug. 
All dates will be displayed in DDMMMYYYY format. 
7.1.1 
First Dose of the Study Drug 
The dose of the study drug taken on the day prior to surgery will count as the first dose of the 
study drug. 
It is possible that a subject is scheduled to have their surgery on a certain date, and according 
to the protocol, they take a drop of the study drug one day prior, however, then the surgery is 
rescheduled to a later date. In this case the subject would keep the IP, stop taking it, and apply 
a new drop before the new scheduled date of surgery. The very first drop taken prior to the 
date of cancelled surgery will count as the first dose of the study drug only for the purposes of 
determining the treatment-emergent status of AEs. It will not count as the first dose of the 
study drug for any other purposes, including, but not limited, to the following: 
1. definition of baseline; 
2. reference date for calculation of relative days; 
3. calculation of study drug exposure and compliance. 
Instead, the dose taken prior to the actual surgery will be considered as the first dose of the 
study drug. 
7.2 
Subject Disposition 
The number of subjects screened in the study, randomized to treatment, included in the Safety, 
PP, mITT populations, prematurely discontinued from the study (along with the reasons for 
discontinuation) will be calculated.  The percentages will be based on the number of subjects 
randomized to each treatment group.  Percentages for discontinuation reasons will be based on 
the sub-population of subjects who discontinued from the study. 


Statistical Analysis Plan  
 
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Number and percentage of subjects enrolled by site will be tabulated for all enrolled subjects, 
Safety, mITT, and PP populations. 
7.3 
Demographic and Baseline Characteristics 
Demographic characteristics will include: 
• age;  
• gender;  
• race;  
• ethnicity; 
Baseline characteristics include: 
• height, weight, body mass index (BMI) 
• iris color 
• aqueous cells grade for the study eye 
• aqueous flare grade for the study eye 
• ocular pain grade for the study eye 
Descriptive statistics will be presented for age (years), height, weight and BMI.  Frequency 
counts and percentages will be presented for race, ethnicity, iris color and baseline grades.  
Height will be reported in centimeters and weight in kilograms. 
Age will be derived from Informed Consent Signed Date (INFCSD) and Date of Birth (DOB) 
as the number of whole years between those two dates. 
Demographic and baseline characteristics will be evaluated for comparability across treatment 
groups in the following manner.  Continuous variables (age, height, weight, BMI) will be 
analyzed with an ANOVA with factors of treatment and investigational site.  Overall p-value 
for the global null hypothesis of all groups being equal will be displayed.  Categorical 
variables (gender, ethnicity, race, iris color, baseline grades) will be analyzed with a Cochran-
Mantel-Haenszel general association test, stratified by investigational site. 
These analyses will be performed for Safety, mITT, and PP populations. 
All parameters reported during screening or baseline phase (including informed consent 
information, inclusion/exclusion criteria, randomization information, method of contraception, 
etc.) will be presented in by-subject listings. 


Statistical Analysis Plan  
 
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7.4 
Medical History 
Medical history will be summarized by MedDRA (version 20.1) System Organ Class (SOC) 
and Preferred Term for the safety population.  Each subject will be counted once within each 
applicable SOC and Preferred Term. All medical history information collected on the eCRF 
will also be listed. 
7.5 
Protocol Deviations 
Protocol deviations will be derived algorithmically (programmable) as well as reported by 
sites (observable). Each protocol deviation will be classified as minor or major.  In the case 
there are differences in the programmable vs. observable protocol deviations, the 
programmable protocol deviation will take precedence. Specific deviation and their severity 
are defined in the separate Protocol Deviations List document. 
All major protocol deviations will be summarized by deviation category and treatment group. 
This analysis will be performed for the Randomized set. 
7.6 
Cataract Surgery 
All details of the surgery captured on the eCRF will be listed. 
7.7 
Efficacy Analyses  
7.7.1 
Analyses of Primary Endpoint 
The primary efficacy endpoint is the proportion of subjects with cure at Visit 5 (end of the 
study on Day 14+/-2). A subject is defined as cure if they have a score of 0 for aqueous cells, 
a score of 0 for aqueous flare and a score of no more than 3 for pain in the study eye. A 
subject is defined as failure if they have a score of >0 for aqueous cells, or score of >0 for 
aqueous flare or a score of >3 for pain in the study eye.  
 
 
 
 
 
 


Statistical Analysis Plan  
 
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The denominator for percentages will be the number of subjects with either cure or failure, i.e. 
subjects without a valid assessment will be excluded. 
7.7.1.1 
Analysis of clinical equivalence of test and reference treatments 
A two-sided, continuity-corrected, 90% confidence interval on the Test-to-Reference 
difference for the proportion of subjects with cure will be constructed.  Bioequivalence will be 
established if the 90% confidence interval for the difference is contained within the interval [-
0.20, +0.20] for the PP population. 
Analysis of bioequivalence will be performed on the PP population. 
7.7.1.2 
Analysis of superiority to placebo 
The evaluation of superiority will be conducted separately for the Test treatment versus the 
Placebo treatment and for the Reference treatment versus the Placebo treatment, comparing 
the proportions of subjects with cure.  The analysis will be conducted using two-sided Fisher’s 
exact test.  
Superiority will be established if the cure proportion for each active treatment is greater than, 
and statistically significantly different from (p < 0.05 for the Fisher’s test) that of the Placebo 
for the mITT population.  Analysis of superiority will be performed on the mITT population. 
7.7.2 
Analyses of Individual Efficacy Parameters 
Aqueous cells, aqueous flare and ocular pain will be assessed at Visits 1, 3, 4 and 5. Aqueous 
cells will be assigned a grade from 0 (None) to 4 (Greater than 30 cells) (see section 11.2 for 
complete scale); aqueous flare a grade from 0 (No visible flare when compared with the 
normal eye) to 3 (Very dense flare) (see section 11.3 for complete scale). Ocular pain will be 
graded from 0 (None) to 5 (Severe) (see section 11.4 for complete scale). 
Number and percentage of subject at each grade for aqueous cells, aqueous flare and ocular 
pain in the study eye will be tabulated by visit. This analysis will be performed for both mITT 
and PP populations. 


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7.8 
Safety Analyses 
7.8.1 
Adverse Events  
Adverse Events will be coded using the MedDRA, Version 20.1, AE coding system for 
purposes of summarization. 
Only Treatment Emergent Events (TEAEs) will be used for the summary analysis.  An AE 
will be considered as treatment-emergent if the time of onset is after the time of the first study 
drug administration or if it increased in severity during the study period.  AEs with unknown 
start dates will be counted as treatment-emergent unless the AE resolution date is prior to the 
study drug start date.  If the start date is partially missing, then month and year (when 
available) will be used to determine if the event occurred prior to or post dosing. 
A TEAE is considered as treatment-related if it is recorded as Related on the eCRF.  In case 
the relatedness was not assessed, the most conservative result – related – will be chosen for 
the analysis. 
An overall summary will include, by treatment group and overall, the number of TEAEs and 
the number and percentage of subjects reporting at least 1 TEAE, as well as number of TEAEs 
in the following categories: 
• Any TEAE, 
• Treatment-related TEAE, 
• Serious TEAE, 
• TEAE leading to discontinuation of the study medication. 
The following TEAE frequency tables will be prepared summarizing the number and 
percentage of subjects reporting at least one TEAE by MedDRA SOC and PT: 
• All TEAEs, 
• TEAEs by Severity, 
• TEAEs by Relationship to Study Medication. 
These AE summaries will be presented in alphabetical order of SOC and preferred terms. 
Additionally, TEAEs will be summarized by the preferred terms in the descending order of 
frequency in the total treatment group.  In this table a p-value from Fisher's exact test 


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comparing event rates between the Test and the Reference treatment groups will be provided 
for those preferred terms that have frequency > 1% in either Test or Reference group. 
A subject experiencing the same AE multiple times will only be counted once for that 
preferred term.  Similarly, if a subject experiences multiple AEs within the same system organ 
class, that subject will be counted only once in that system organ class. In summaries by 
severity and relationship each subject will be counted with the highest applicable severity and 
the closest applicable relationship. 
All information pertaining to adverse events noted during the study will be listed by subject, 
detailing verbatim, preferred term, system organ class, start date, stop date, intensity, outcome, 
action taken, and causal relationship to the study drug.  The adverse event onset will also be 
shown relative (in number of days) to the date of first administration of the study drug.  In 
addition, the adverse event duration (if AE Stop Date is available) will be evaluated as below 
and presented (in number of days). 
                          AE Duration = AE Stop Date – AE Start Date + 1 
7.8.2 
Laboratory Tests 
The following laboratory tests will be performed at Visit 1 Screening and Visit 5 Day 14. 
 
Serum Chemistry 
ALT 
AST 
BUN 
Total Bilirubin 
Glucose 
Creatinine 
Hematology 
Hemoglobin 
Total WBC count with differentials 
Urinalysis 
Appearance 
Specific Gravity 
Protein 
pH 
Microscopic examination 
 
If warranted, other tests or examinations may be performed at the discretion of the 
investigator. 
Actual values and changes from baseline for laboratory test results will be summarized 
descriptively by visit and treatment group. Test results will be presented in conventional units. 
Additionally, numeric Serum Chemistry, Hematology and Urinalysis results will be classified 
as Low (below the reference range), Normal (within the reference range) or High (above the 
reference range). Categorical Urinalysis results will be classified as Normal or Abnormal. 
Shifts among these categories between baseline and Visit 5 Day 14 will be provided. 
All results will be listed. 


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7.8.3 
Vital Signs 
Vital signs, including systolic and diastolic blood pressure, pulse rate, respiratory rate and 
body temperature will be assessed at all study visits. Overall interpretation will be recorded as 
Normal, Abnormal Not Clinically Significant or Abnormal Clinically Significant. 
Height and weight will be measured and BMI will be calculated at Visit 1 Screening and Visit 
5 Day 14+/-2. 
Actual values and changes from baseline for vital signs (including height, weight an BMI) will 
be summarized descriptively by visit and treatment group. Overall interpretation will be 
summarized categorically by visit and treatment group. All vital signs results (including 
height, weight and BMI) will be listed. 
7.8.4 
Physical Examination 
Physical examination will be performed at Visit 1 Screening and Visit 5 Day 14+/-2. The 
following body systems will be examined: General Appearance, Skin, HEENT, Heart, Lungs, 
Musculoskeletal System, Lymph Nodes, Neurological Systems, Gastrointestinal System, 
Genitourinary System, Extremities and Other if necessary. Each body system will be 
classified as Normal, Abnormal Not Clinically Significant or Abnormal Clinically Significant. 
Number and percentage of subjects with each assessment result will be tabulated by body 
system, visit and treatment group. All results will be listed. 
7.8.5 
Visual Acuity 
Subjects’ visual acuity will be measured during Visit 1 Screening, Visit 4 Day 7 +/-2and Visit 
5 Day 14+/-2. Visual acuity will be tested using the subjects best-available spectacle 
correction with a Snellen chart.  Best Corrected Visual Acuity will be recorded in Snellen 
units.   
Snellen denominator and its change from baseline will be summarized descriptively by eye 
(study or non-study) visit and treatment group.  
All results will be listed. 
7.8.6 
Slit Lamp Examination 
Complete slit-lamp evaluation including evaluation of eyelids, conjunctiva, sclera, cornea and 
iris will be performed at Visit 1 Screening, Visit 3 Day 1, Visit 4 Day 7+/-2 and Visit 5 Day 
14+/-2. Each eye area examined will be classified as Normal, Abnormal Not Clinically 
Significant or Abnormal Clinically Significant. 
Number and percentage of subjects with each assessment result will be tabulated by eye 
(study or non-study), eye area, visit and treatment group. All results will be listed. 


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7.8.7 
Intraocular Pressure 
Intraocular pressure will be measured in mmHg at Visit 1 Screening, Visit 3 Day 1, Visit 4 
Day 7+/-2 and Visit 5 Day 14+/-2. 
Intraocular pressure and its change from baseline will be summarized descriptively by eye 
(study or non-study) visit and treatment group. 
All results will be listed. 
7.8.8 
Dilated Fundus Examination 
A dilated fundus examination will be administered at Visit 1 Screening and Visit 5 Day 
14+/-2. In it, appropriate eye drops will be used to dilate or enlarge the pupil in order to 
obtain better view of the fundus of the eye. Once the pupil is dilated, an ophthalmoscope or 
indirect lens will be used to view the eye structures: 
1. Optic Nerve Head: classified as Normal or Glaucomatous; horizontal and vertical 
cup/disc ratio measured. 
2. Lens: examined for opacities and other challenges; classified as Normal, Abnormal Not 
Clinically Significant or Abnormal Clinically Significant 
3. Vitreous: classified as Normal, Abnormal Not Clinically Significant or Abnormal 
Clinically Significant 
4. Retina: classified as Normal, Abnormal Not Clinically Significant or Abnormal 
Clinically Significant 
Number and percentage of subjects with each kind of assessment will be tabulated by eye 
(study or non-study), fundus structure, visit and treatment group. Horizontal and vertical 
cup/disc ratios will be summarized descriptively by eye (study or non-study), visit and 
treatment group. 
7.8.9 
Exposure to Product 
The subjects will be instructed to use the diary to document all doses taken.  Additionally, the 
dose taken one day prior to the surgery will be recorded on the eCRF. 
Compliance with scheduled application of IP will be determined from the subject’s diary as 
[Actual number of doses] / [Planned number of doses] * 100%, where  
• Actual number of doses will counted from the subject diary and relevant eCRF pages; 
• Planned number of doses is 17 (i.e. Days -1 through Day 14 with two doses taken on 
Day 0). 
Number of missed doses will be calculated as the number of planned dosing time-points when 
the study drug was not taken during the 16 days starting with the date of the first dose. There 
is one dosing time-point per each day, except the day of Visit 2 Day 0, when there are two 
planned time-points, before the surgery and after the surgery. 


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Subjects who missed dosing for more than 3 consecutive days will be considered non-
compliant and will be excluded from the PP population.  
Subjects can be additionally excluded from the PP population due to non-compliance, if the 
Investigator's and Sponsor's review of their dosing times suggests a clinically meaningful 
departure from the once-daily dosing pattern.   
Subjects will be considered compliant if they administer at least 14 doses and not more than 
20 doses, with no more than 3 consecutive missed dosing days.  The compliance will be 
analyzed using the descriptive statistics by treatment group.  The proportion of compliant vs. 
non-compliant subjects will be tabulated for each treatment. 
Duration of exposure will be calculated as Date of last use of the study drug – Date of first use 
of the study drug + 1.  Duration of exposure will be summarized descriptively by treatment 
group. 
Compliance, number of doses and duration of exposure will be summarized for the Safety and 
mITT populations. 
7.8.10 
Exposure to Concomitant Medication 
Medication or non-drug therapy will be classified as prior, if the end date is known and is 
prior to the first use of the study drug.  Medications and non-drug therapies that are ongoing 
or ended after the first use of the study drug will be classified as concomitant.  If the end date 
of the medication or non-drug therapy is unknown, it will also be considered concomitant. 
The concomitant medications will be summarized by preferred term for each treatment group 
as coded by the World Health Organization Drug (WHODRUG) dictionary Sept-2017 and be 
listed in a by-subject listing.  Prior medications will be listed only. 
7.8.11 
Other assessments 
Details of contraception method used by the subjects will be listed. 
Urine pregnancy test will be performed for females of childbearing potential at Visit 1 
Screening, Visit 2 Day 0 and Visit 5 Day 14. Results will be listed. 
Details of the study drug and diary accountability will be listed. 
General comments collected on the eCRF will be listed. 
8. 
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES  
There are no changes from the protocol-specified analyses. 


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9. 
LIST OF PLANNED TABLES, FIGURES, AND LISTINGS 
See separate document with the table, figure and listing shells. 
10. 
LITERATURE CITATIONS / REFERENCES 
1. Study Protocol: "A randomized, multicenter, double masked, placebo controlled, 
parallel group, bioequivalence study to evaluate the clinical equivalence and safety of 
Nepafenac 0.3% ophthalmic suspension (
 
Actavis LLC) with Ilevro™ (Nepafenac ophthalmic suspension), 0.3% of Alcon 
Laboratories, Inc. for the treatment of pain and inflammation associated with cataract 
surgery", version 2.0 dated Feb 22, 2018. 
 


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11. 
APPENDICES 
11.1 
Study visit Schedule 
Visit Details 
Visit 1 
Telephone Call Visit 2 
Visit 3 
Visit 4 
Visit 5 
Study Activities 
Day -7 to -1    
Screening/ 
Baseline/ 
Randomization 
Day -1 
Pre-Operative    
Telephone Call 
Day 0  
The Day of       
Cataract    
Surgery 
Day 1  
One Day After 
Cataract 
Surgery 
Day 7 + 2 days 
Follow-up   
visit 
Day 14 + 2 days   
(End  
of Study / Early   
Discontinuation) 
Informed Consent Process 
× 
Medical History & 
Demographics 
× 
Pre-Operative Call 
 
× 
 
 
 
 
Physical Examination 
× 
 
 
 
 
× 
Vital Signs  
× 
 
× 
× 
× 
× 
Inclusion/Exclusion 
Review 
× 
Schedule the day for 
Cataract Surgery 
× 
Assessment of Ocular Pain 
× 
× 
× 
× 
Visual Acuity 
× 
 
× 
× 
Slit Lamp Examination 
× 
× 
× 
× 
Intraocular Pressure 
× 
× 
× 
× 
Fundus Examination 
× 
× 


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Laboratory Assessments 
(hematology, 
biochemistry and urine 
analysis) 
× 
× 
Urine Pregnancy Test 
× 
 
× 
× 
Dispense/Administer Study 
drug 
× 
 
× 
× 
× 
× 
Dispense Subject Diary 
× 
× 
× 
Retrieval/Review of Subject 
Diary 
× 
× 
Retrieval of Study 
Medication 
× 
Concomitant Medication 
Assessment 
× 
 
× 
× 
× 
× 
Adverse Event Assessment 
× 
× 
× 
× 
× 
× 
 
11.2 
Aqueous Cells Scale  
Grade 
Aqueous Cells: Determined using a narrow slit beam (0.5 mm width at least 
8mm length) at maximum luminance. Pigment and red blood cells are to be 
0 
None 
1 
1 to 5 cells 
2 
6 to 15 cells 
3 
16 to 30 cells 
4 
Greater than 30 cells 
11.3 
Aqueous Flare Scale 
Grade 
Aqueous Flare: Determined using a narrow slit beam (0.5 mm width at least 
8mm length) at maximum luminance. 
0 
No visible flare when compared with the normal eye. 


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1 
Mild-Flare visible against dark pupillary background but not visible against iris 
background. 
2 
Moderate-Flare is visible with the slit-lamp beam aimed onto the iris surface as 
well as the dark pupillary background. 
3 
Severe-Very dense flare. May also present as a “hazy” appearance of anterior 
segment structures when viewed with low power magnification of the slit-lamp. 
Present as pronounced Tyndall effect. 
11.4 
Ocular Pain Scale 
Grade 
Ocular Pain: A positive sensation of the eye, including foreign body sensation, 
stabbing, throbbing or aching. 
0 
None- absence of positive sensation 
1 
Patient reports presence of mild sensation or discomfort typical of post-
operative ocular surgery, e.g., diffuse or focal foreign body sensation, mild 
transient burning or stinging. 
2 
Mild- mild, tolerable aching of the eye. 
3 
Moderate- moderate or more prolonged aching sufficient to require the use of 
over-the-counter analgesics (e.g. acetaminophen). 
4 
Moderately Severe- More prolonged aching requiring the use of any over-the- 
counter analgesics other than acetaminophen. 
5 
Severe- Patient reports intense ocular, periocular, or radiating pain (e.g., 
constant or nearly constant sharp stabbing pain, throbbing or aching, etc.) 
requiring prescription analgesics. 
11.5 
Code Fragments  
Superiority analysis 
proc freq data=<dataset> 
tables <treatment>*<cure> / fisher; 
run; 
 


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Note: this analysis needs to be performed separately for test and reference treatments on a dataset containing only test and placebo 
or reference and placebo treatment subjects. 
 
Clinical equivalence analysis 
proc freq data=<dataset> 
tables <treatment>*<cure > / riskdiffc; 
run; 
 
Note: this analysis needs to be performed on a dataset containing test and reference treatment subjects only.