The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Phase: NA
Conditions: Asthenopia, Myopia
Sponsor: Pete Kollbaum, OD, PhD

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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The Impact of Soft Contact Lens Attributes on 
Symptoms Associated With Digital Eye Strain in 
Symptomatic Soft Contact Lens Wearers 
 
NCT03585790 
Unique Protocol ID: Kollbaum001 
 
 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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TITLE:  The impact of soft contact lens surface and optics on symptoms associated with digital eye 
strain in symptomatic soft contact lens wearers 
 
 
INVESTIGATORS:  Pete Kollbaum, OD, PhD; Dawn Meyer OD 
 
 
INVESTIGATION SITE:  Indiana University  
 
 
STUDY OVERVIEW  
Eye fatigue is a growing concern for the vision community.  In large part, this eye fatigue is thought to be 
exasperated by digital device use, which permeates most all of everyone’s lives including work and play.  
Upwards of three-quarters of the general population may express symptoms of eye fatigue, yet may not 
know that it is not normal, or that there may be methods to reduce or eliminate eye fatigue.  Despite its 
prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens 
surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a 
combination of these or other causes.  The current study aims to systematically investigate the 
incremental benefits in ameliorating eye fatigue provided by (a) an optimized contact lens spherical 
prescription, (b) a lens with highly wettable surface, and (c) a lens with optics to aid the accommodative 
and convergence systems (in addition to a highly wettable lens surface).  
 
 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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PROTOCOL SYNOPSIS 
KEY OBJECTIVE 
1. Subject-reported eye fatigue (0-100 rating scale) 
 
KEY ENDPOINTS 
Superiority (change) of subject-reported rating >8 rating units  
STUDY DESIGN 
The proposed study design is a subject masked, 2 x 2 randomized, crossover 
(with a baseline reference) comparing the difference in fatigue rating 
relative to baseline, where the baseline the is the response for subject 
habitual lenses, with optimized power, worn on their typical (e.g. 2 week, 1 
month) replacement schedule. The study design is balanced for residuals with 
four sources of variation: lens, sequence group, period and participant. To 
adjust for individual differences prior to study entrance, difference scores 
will be used as response variables in the analyses.  The same number of 
participants will be randomized to each of two possible lens sequence 
groups: {A, B}, {B, A}.  Baseline will be evaluated prior to any testing of A 
and B.  Specifically, A and B are:  
Baseline = Subject habitual lenses, with optimized power, habitual 
replacement 
A = DAILIES TOTAL 1 sphere (DT1) 
B = DAILITES TOTAL 1 MULTIFOCAL (DT1 MF) 
 
Subjects will be randomized into two equal groups of those that have each 
of the two sequences ({A, B}, {B, A}) (balanced Latin Square design).   
 
STATISTICAL 
CONSIDERATIONS 
 
Sample size N=42 
Hypothesis 
1. Subject-reported eye fatigue difference scores (lens A – baseline) 
comparing the change in response for lens A to baseline are <0 (i.e. 
fatigue rating was improved with lens A over baseline).  This 
hypothesis tests if a lens with enhanced surface (DT1) provides 
better fatigue ratings than a typical lens without an optimized 
surface (optimized habitual).  
2. Subject-reported eye fatigue difference scores (lens B – baseline) 
comparing the change in response for lens B to baseline are <0 (i.e. 
fatigue rating was improved with lens B over baseline).  This 
hypothesis tests if a lens with enhanced surface and enhanced 
optics (DT1 MF) provides better fatigue ratings than a typical lens 
without an enhanced surface or enhanced optics (optimized 
habitual). 
3. Subject-reported eye fatigue difference scores (lens B – lens A) 
comparing the difference in response for lens B to lens A are <0 (i.e. 
fatigue rating was improved with lens B over lens A).  This 
hypothesis tests if a lens with enhanced surface AND enhanced 
optics (DT1 MF) provides better fatigue ratings than a lens with only 
enhanced surface (DT1) characteristics.  
 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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Data analysis SAS PROC MIXED (or R LMER) to fit linear mixed effects model to the 
normalized ratings data. 
TEST COMPARATOR 
PRODUCTS 
Baseline = Subject habitual lenses, with optimized power, habitual 
replacement 
A = DAILIES TOTAL 1 sphere 
B = DAILITES TOTAL 1 MULTIFOCAL 
 
INCLUSION/EXCLUSION 
CRITERIA 
1. Self-reported “eye fatigue” at least once per week attributable to 
digital device use with baseline. 
2. Uses a digital device (phone, tablet, computer, etc) at least 4 hours 
per day 
3. Mobile digital device with active data and text plan, able to receive 
email and text messages 
4. Habitual 2-week or monthly silicone single vision hydrogel soft 
contact lens use; habitually wearing lenses for 6 or more hours per 
day for 5 or more days per week for the past 30 days 
5. Habitual soft contact lens prescription optimized over-refraction 
within ±0.25 D  
6. 18-35 years of age 
7. No history of issues of eye alignment or binocularity by self-report 
8. No doctor diagnosed, self-reported accommodative or binocular 
vision issues 
9. No doctor diagnosed, self-reported ocular surface disease or dry 
eye requiring regular, ongoing treatment 
10. The subject must appear able and willing to adhere to the 
instructions set forth in this clinical protocol. 
11. Vertex corrected refractive cylinder must be -0.75 or less.   
12. Visual acuity best correctable to 20/25 or better for each eye 
13. The subject must read and sign the Informed Consent form. 
14. No active conditions that may prevent soft contact lens wear. 
15. Not habitual wearer of any of the test lenses. 
16. Photopic pupil size >=4 mm (normal room illumination ~100 cd/m2) 
 
OFF LABEL 
No. 
CLINICAL SUPPLIES 
REQUESTED FROM 
ALCON 
DAILIES TOTAL 1 sphere 
DAILITES TOTAL 1 MULTIFOCAL 
RESULTS 
DISSEMINATION 
Work will be presented at least one international meeting, such as Global 
Specialty Lens Symposium or ARVO.  The work will also be prepared for 
submission for peer-reviewed publication (e.g. Optometry and Vision 
Science).  Trade publications may also be prepared at Sponsor’s request and 
expense. 
CONFLICT OF INTERST 
None. 
 
 
PROPOSAL SUMMARY 
STUDY 
DURATION 
1 year 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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DURATION OF 
IRB APPROVAL 
1 year 
GCP TRAINING 
Received; 2016-01-12 
TYPE OF STUDY 
Single center 
FUNDING FROM 
OTHER SOURCES 
None. 
 
 
 
 
 
 
 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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RATIONALE AND SIGNIFICANCE:   
According to a recent survey by the Vision Council, nearly 90% of Americans use digital devices for more 
than 2 hours per day, with average use around 8 hours.  Results from this same survey indicate that as 
many as 65% of Americans experience symptoms of eye fatigue as a result of digital device use (Vision 
Council 2016).  Recent work by our group (Kollbaum ARVO 2016) indicates that in another typical 
population 76% of the population suffer from symptoms of eye fatigue, and frequency of reported eye 
fatigue was similar whether individuals wore soft contact lenses or not.  However, of those that wore 
soft contact lenses, they were more likely to describe their eye fatigue as a feeling of “dryness”, whereas 
non-soft contact lens wearers were more likely to describe their eye fatigue as a feeling of “strain”. 
Despite these differences, however, this result indicates that soft contact lenses are not generally the 
cause of eye fatigue reported (e.g. reported eye fatigue is more than just contact lens related dryness), 
and if not the cause, could they be the treatment?  Recent work by our group (Kollbaum ARVO 2016) 
has also identified that sufferers of eyestrain most frequently use descriptors of straining, dryness, and 
tiredness.  This work also found that the sufferers of eyestrain can consistently differentiate and group 
the symptoms of eyestrain into 3 clusters of global (e.g. headache), surface (e.g. dryness), and optical 
(e.g. blurring) sensations.  This result provides confidence that the “affects” of eyestrain are known and 
that they are the main components of eyestrain.  With this knowledge, work on identifying the 
potentially multifaceted cause and possible treatments can then occur in a systematic way. For instance, 
DAILIES TOTAL 1 is a lens with unique surface characteristics that are hypothesized to minimize 
symptoms of dryness.  Accordingly, can it ameliorate reported symptoms of eye fatigue, specifically the 
surface symptom components of eyestrain? Alternatively, could the optical manipulations provided by 
DAILIES TOTAL 1 Multifocal ameliorate both the surface and optical sensations sufferers experience? 
 
Furthermore, a recent double-masked, randomized, bilateral cross-over study of pre-presbyopic subjects 
(Orsborn GSLS 2016) indicates that when two lenses of the same material are compared, one with 
typical single vision optics and one with optimized optics to decrease accommodative need, individuals 
report no change in the surface or dryness component of their eye fatigue, but do report a decrease in 
the optical components of eye fatigue (such as straining).  Accordingly, DAILIES TOTAL 1 multifocal, as a 
single use lens with optimized surface qualities and optimized optics, may be a lens capable of 
ameliorating eye reported eye fatigue by acting on both the surface and optical sensations that are 
believed to be the largest components of eye fatigue (Kollbaum 2016). 
 
The current proposal briefly outlines potential strategies to systematically investigate the questions 
highlighted above.  If the results are favorable, the results may serve to help practitioners understand 
how the DAILIES TOTAL 1 family of products may help ameliorate symptoms of digital eye fatigue. 
 
AIM: To quantify the real-time subject-reported fatigue in symptomatic, non-daily replacement silicone 
hydrogel soft contact lens wearers and the change in symptomology associated with change to DAILIES 
TOTAL 1 (sphere), DAILIES TOTAL 1 multifocal (LO Add), relative to normal replacement of habitual lens.   
 
1. No diagnosis of dry eye or ocular surface disease 
2. Corneal plane cylinder less than or equal to 0.75 D 
3. No diagnosis of any accommodative or convergence problem 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
Page 7 of 12
METHODS:  
 
STUDY DESIGN:  The proposed study design is a subject masked, 2 x 2 randomized, crossover (with a 
reference) comparing the difference in fatigue rating relative to baseline, where the baseline the is the 
response for subject habitual lenses, with optimized power, worn on their typical (e.g. 2 week, 1 month) 
replacement schedule. The study design is balanced for residuals with four sources of variation: lens, 
sequence group, period and participant. To adjust for individual differences prior to study entrance, 
difference scores will be used as response variables in the analyses.  The same number of participants 
will be randomized to each of two possible lens sequence groups: {A, B}, or {B, A}.  Baseline will be 
evaluated prior to any testing of A and B.  Specifically, A and B are:  
Baseline = Subject habitual lenses, with optimized power, habitual replacement 
A = DAILIES TOTAL 1 sphere 
B = DAILITES TOTAL 1 MULTIFOCAL 
 
Note:  To be included in the study, subject-reported eye fatigue at least once per week 
with baseline (optimized habitual lens, habitual replacement schedule) is required.  
 
Subjects will be randomized into two equal groups of those that have each of the two sequences ({A, B}, 
{B, A}) (balanced Latin Square design).   
 
At first visit additional baseline, demographic data, and data will be collected.  Over refraction will be 
performed to determine the optimal habitual prescription.  Subjects will then be dispensed a new pair of 
their habitual lenses to be worn on their same replacement cycle.  Subjects will, however, not be told 
that they were given new lenses, but rather to think that these lenses are the same as the ones they 
brought in.  Daily patient-reported outcome measures will be collected for 7 days ±3 days) of wear.   
 
At the follow-up visit, the subject will be rescreened to assure they still meet the enrollment criteria.  If 
so, in-office measures will be performed. The subject will then be randomized to DT1 sphere or DT1 MF 
Lo add.  Each lens will be worn daily for 7 (±3) days.  After 7 (±3) days in-office measures will be 
collected, and the next lens dispensed.  There will be 4 visits in all. 
Visit 1 = baseline/dispense new optimal habitual on normal replacement schedule 
Visit 2 = follow-up habitual/dispense pair 1 
Visit 3 = follow-up pair 1/dispense pair 2 
Visit 4 = follow-up pair 2/exit 
 
 
SUBJECTS 
 
Enrollment criteria: 
1. Self-reported “eye fatigue” at least once per week WITH OPTIMIZED HABITUAL LENS 
attributable to digital device use 
2. Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day 
3. Mobile digital device with active data and text plan, able to receive email and text messages 
4. Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually 
wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days 
5. Habitual soft contact lens prescription optimized over-refraction within ±0.25 D  
6. 18-35 years of age 
7. No history of issues of eye alignment or binocularity by self-report 
8. No doctor diagnosed, self-reported accommodative or binocular vision issues 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
Page 8 of 12
9. No doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing 
treatment 
10. The subject must appear able and willing to adhere to the instructions set forth in this clinical 
protocol. 
11. Vertex corrected refractive cylinder must be -0.75 or less.   
12. Visual acuity best correctable to 20/25 or better for each eye 
13. The subject must read and sign the Informed Consent form. 
14. No active conditions that may prevent soft contact lens wear. 
15. Not habitual wearer of any of the test lenses. 
16. Photopic pupil size >=4 mm (normal room illumination ~100 cd/m2) 
 
 
SAMPLE SIZE DETERMINATION 
The comparison of interest is DT1 sphere and DT1 MF Lo add, so the sample size calculation was based 
on detecting a difference between these 2 lenses. 
 
1. The proposed study design is a 2 x 2 crossover design balanced for residuals with four sources of 
variation: lens, sequence group, period and participant. The same number of participants will be 
randomized to each of two possible lens sequence groups: {A, B}, {B, A}.  Because each lens is 
preceded by every other lens exactly twice we can check for lens carryover effects; if the 
carryover effect is the same for each lens type, these effects cancel when comparing differences 
in lens means.  
2. The primary outcome measures are difference in subjective ratings for the current trial lenses 
normalized to the ratings made at baseline wearing habitual lenses, i.e., ratings will be assessed 
using an integer scale of 0-100 with semantic anchoring and the rating at baseline will be 
subtracted from the rating made with each one of the three trial lenses.   
3. Ideally, the sample size analysis would incorporate ‘known’ estimates of the mean, variance and 
(autoregressive) covariance of subjective ratings for the habitual and each of the three study 
lenses measured in a comparable experimental design to the proposed three-arm crossover 
study.  Here, we rely on ratings data from previous CORL studies to inform the power analysis. 
Specifically, we have typically observed (1) individual differences in baseline ratings with 
habitual lenses, (2) period effects such that ratings that are, on average, lower and also more 
variable at follow-up assessments, and (3) moderate to strong within-participant correlations in 
ratings assessed with different study lenses.  A limitation of the previous data is that that we 
have typically observed non-significant LENS*PERIOD interactions in the fitted linear mixed 
regression models.  So, for the current analysis, we base the effect size for the a priori power 
analysis on a desired (i.e., clinically relevant) pairwise difference of 9 units in subjective rating.  
Previous data suggests that the expected variability (σ) in ratings during follow-up assessments 
is ~15-19 rating units with correlations ranging from 0.50-0.60. 
4. To arrive at the initial (unadjusted) sample size estimate, we performed a power analysis for a 
within-participants comparison of the mean difference in the normalized ratings (i.e., change re: 
rating at baseline wearing pristine habitual lens) for two study lenses.  Specifically, although we 
will initially fit linear mixed effects models to the data and obtain least-squares estimates of the 
pairwise mean differences in rating, we can the required sample size to power a paired-samples 
t test for normal (continuous) mean difference  
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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Note that the paired-sample t test assumes normally distributed data and requires N ≥ 2. The 
test statistics are 
𝑡𝑡= 𝑁𝑁1/2 ቀ
𝑑𝑑ത−𝜇𝜇0
𝑠𝑠𝑑𝑑ቁ ~ 𝑡𝑡(𝑁𝑁−1, 𝛿𝛿)  or, equivalently, 𝑡𝑡2~𝐹𝐹(1,𝑁𝑁−1, 𝛿𝛿2) 
where 𝑑𝑑̅ and 𝑠𝑠𝑑𝑑 are the sample mean and standard deviation of the differences, and  
𝛿𝛿= 𝑁𝑁1/2 ൬
𝜇𝜇𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑−𝜇𝜇0
𝜎𝜎𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑൰  and  𝜎𝜎𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑= (𝜎𝜎1
2 + 𝜎𝜎2
2 −2𝜌𝜌𝜎𝜎1𝜎𝜎2)1/2  
represent the non-centrality parameter and standard deviation of the paired difference scores, 
respectively.   
5. Our calculation assumed a standard deviation of 18 rating units. With equal variances, the 
estimated 𝜎𝜎𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑= (𝜎𝜎1
2 + 𝜎𝜎2
2 −2𝜌𝜌𝜎𝜎1𝜎𝜎2)1/2 =  18ඥ2 ∗(1 −𝜌𝜌).   We varied both the sample 
mean between 7 and 12 units in steps of 1 unit and the within-participant correlation between 
0.40 and 0.60 in steps of 0.05 to compute the number of pairs of observations needed to 
achieve a minimum of 80% power at significance level of α=0.05 and a non-directional test (Ho ≠ 
0 mean difference).  Table 1 and Figure 1 show the results under this scenario.  In Table 1, rows 
corresponding to a mean rating difference of 9 units are enclosed in the box.  For correlation of 
0.50, the estimated number of participants required to detect a moderate effect size of 
9/18=0.50 is 34.  Because we want to balance the design for residuals, a total sample size of 
N=36 (unadjusted for dropout) is needed to assign 6 participants to each sequence group. To 
detect the same effect size with slightly weaker correlations the sample size should be increased 
to N=42.   Figure 1 shows that rating differences ≥ 9 units could be detected for correlations ≥ 
0.40 with sample of 40 or fewer participants.   
Table 1  
Computed N Pairs 
Index 
Mean 
Difference 
Correlation 
Actual 
Power 
N 
Pairs 
1 
7 
0.40 
0.805 
65 
2 
7 
0.45 
0.807 
60 
3 
7 
0.50 
0.801 
54 
4 
7 
0.55 
0.803 
49 
5 
7 
0.60 
0.805 
44 
6 
8 
0.40 
0.803 
50 
7 
8 
0.45 
0.803 
46 
8 
8 
0.50 
0.803 
42 
9 
8 
0.55 
0.803 
38 
10 
8 
0.60 
0.803 
34 
11 
9 
0.40 
0.804 
40   
12 
9 
0.45 
0.806 
37   
13 
9 
0.50 
0.808 
34   
14 
9 
0.55 
0.810 
31   
15 
9 
0.60 
0.814 
28   
16 
10 
0.40 
0.806 
33 
17 
10 
0.45 
0.801 
30 
18 
10 
0.50 
0.809 
28 
19 
10 
0.55 
0.802 
25 
20 
10 
0.60 
0.812 
23 
21 
11 
0.40 
0.812 
28 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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22 
11 
0.45 
0.815 
26 
23 
11 
0.50 
0.818 
24 
24 
11 
0.55 
0.802 
21 
25 
11 
0.60 
0.804 
19 
26 
12 
0.40 
0.815 
24 
27 
12 
0.45 
0.811 
22 
28 
12 
0.50 
0.807 
20 
29 
12 
0.55 
0.802 
18 
30 
12 
0.60 
0.822 
17 
 
Figure 1 
 
Based on this, we aim to enroll 44 subjects, so as to complete 42 throughout the study duration. 
 
 
LENSES 
The spherical power of all corrections will be monocularly, distance vision optimized.  Specifically, lens 
powers may not be the same for all types of lenses, due to power-targeting during manufacture, on-eye 
flexure, etc.  Optimization entails providing the lens for each eye that monocularly provides an objective 
improvement in acuity and up to -0.25 D more for any patient-reported quality improvement.  All lenses 
will be over-labeled, so as to, as best as possible, preserve masking (less blister pack shape).  Of note, 
subjects will not be able to tell the difference between DT1 and DT1 MF (Lo add) because of the same 
blister shape, but may be able to tell a difference between these and habitual.  
 
 
OUTCOME MEASURES 
Primary: 
1. Subject-reported eye fatigue (0-100 rating scale, 0=optimal) 
 
 
 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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STATISTICAL ANALYSIS 
Our primary analysis will use SAS PROC MIXED (or R LMER) to fit linear mixed effects model to the 
normalized change from baseline ratings data.  Because the proposed design is balanced for residuals 
we could fit the data using PROC GLM if there are no missing data to obtain identical parameter 
estimates.  A separate model will be fit to the data for each rating scale tested.  All four sources of 
variation (lens, sequence group, period and participant) will be included as class variables.   We will also 
test for a carryover effect by including a character-valued variable whose value represents the lens worn 
in the previous period (‘0’ assigned to the carryover variable for the first period).  Thus, the initial 
models used to analyze the data include effects for sequence group, lens, period and the overall 
carryover.  Participant-within-sequence group will be included as a random effect.  Although LSMEANS 
due to lens will not be estimable in these models, differences between trial lenses are if we assume the 
carryover effect is the same for each lens type.  Evidence of a significant Lens-by-Period interaction will 
be handled by running separate analyses within each period using, for example, a two-sample 
independent samples t-test.  
 
The analysis will not specifically make p-value adjustment for multiple testing as the comparisons are 
planned in advance.  The omnibus in an (M)ANOVA or parameter estimates for a factor in a Linear 
Mixed-Effects regression model provide the protection against "family-wise" error, i.e., once the 
omnibus test (or saturated model) detects an effect at say alpha=0.05, doing subsequent pairwise 
comparisons on different levels of the factor(s) can no longer generate a false alarm (Type I error)!   
  
Having said that, as a follow-up, exploratory technique, we may also use Dunnett’s method for 
performing all pairwise comparisons of the means and other margins across levels of our categorical 
variables (e.g., lens) after model estimation.  This method adjusts the p-values and confidence intervals 
for multiple comparisons involving a fixed reference category (i.e., the control lens).    
 
 
PUBLICATION PLAN:  Work will be presented at least one international meeting, such as Global Specialty 
Lens Symposium or ARVO.  The work will also be prepared for submission for peer-reviewed publication 
(e.g. Optometry and Vision Science).  Trade publications may also be prepared at Sponsor’s request and 
expense. 
 
 
 

CONFIDENTIAL STUDY PROTOCOL (v. 2017-11-08) 
 
Pete Kollbaum, OD, PhD; Indiana University 
 
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TIMELINE:  (estimated) 
Contract approval: unknown, estimate 1 month 
Human subjects approval:  1 month, concurrent to above 
Project setup: 1.5 month, concurrent to above 
Recruitment: 1 month 
Data collection: 3 months 
Data analysis: 3 months 
Report writing: 3 months