A Comparative Study on Functional Vision in Astigmatic Patients: DAILIES TOTAL1 Toric Contact Lenses vs. Spherical Equivalent Contact Lenses in Asian Eyes
Phase: NA
Conditions: Comparative Effectiveness Research
Sponsor: Mopsy Research

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Proposal Title:  
A Comparative Study on Functional Vision and Digital Device Usage in 
Astigmatic Patients: DAILIES TOTAL1 Toric Contact Lenses vs. Spherical 
Equivalent Contact Lenses in Asian Eyes 
Manki Chan, Principal Researcher, Mopsy Research 
 
DATE: 20 DEC 2023 
 
 

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Background: 
In today's digital age, individuals spend a significant amount of time using digital devices [1]. This is 
notably challenging for individuals with astigmatism, a condition that can impair visual acuity when 
using these devices [2]. Despite the prevalence of astigmatism, toric contact lens technology, which 
can potentially improve visual acuity for these individuals, remains underused [3][4]. Many eye care 
practitioners opt for spherical lenses due to perceived complexities of fitting and considerations of 
cost-effectiveness [5][6]. 
DAILIES TOTAL1® for Astigmatism contact lenses, the first and only daily disposable Water Gradient 
toric contact lenses, can potentially address this issue. These lenses represent a significant innovation 
in toric contact lens technology, offering a unique combination of breathability and exceptional 
comfort. The lenses utilize Water Gradient Technology, creating a gradual transition in water content 
from the core to the surface of the lens, with the water content approaching 100% at the lens surface. 
This technology enables these lenses to offer a combination of high breathability and exceptional 
comfort. 
 
Unmet Medical Need: 
Although toric lenses, including DAILIES TOTAL1® for Astigmatism, have been shown to improve visual 
acuity in astigmatic patients, their impact on real-world visual performance, particularly when using 
digital devices, is less understood [1]. Additionally, while many practitioners gravitate towards spherical 
lenses, astigmatic patients could greatly benefit from the comfort and visual acuity provided by 
DAILIES TOTAL1® for Astigmatism contact lenses. 
Gaining insights into the real-world visual performance of astigmatic patients when using DAILIES 
TOTAL1® for Astigmatism contact lenses could provide valuable information to eye care practitioners 
and patients. This could potentially encourage the broader adoption of DAILIES TOTAL1® for 
Astigmatism contact lenses, improving the visual experience for astigmatic patients and addressing an 
unmet medical need. 
 
 
 

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Scientific Rationale: 
Previous clinical studies have demonstrated the benefits of toric contact lenses in improving visual 
acuity in astigmatic patients[5]. However, these studies primarily used traditional high-contrast, high-
luminance visual acuity testing, which may not accurately reflect the visual demands of real-world 
tasks, especially those involving digital devices [7][8]. 
DAILIES TOTAL1® for Astigmatism contact lenses stand out due to their unique Water Gradient 
Technology and Precision Balance 8|4® Lens Design. The gradual transition in water content from the 
core to the surface of the lens, with the water content approaching 100% at the lens surface, enables 
a combination of high breathability and exceptional comfort. The lens design ensures a quick and 
stable fit, with 99% first-lens fit success. Additionally, these lenses feature SmarTears® Technology, 
which releases an ingredient found naturally in tears to stabilize the lipid layer of the tear film, further 
promoting comfort for the wearer. 
This study seeks to extend previous findings by evaluating the impact of DAILIES TOTAL1® for 
Astigmatism Contact Lenses on subjective and objective visual performance outcomes in astigmatic 
patients using digital devices [9]. This will involve the use of advanced digital real-world and patient-
reported outcome tools, providing a comprehensive evaluation of vision beyond acuity alone. The goal 
is to ascertain whether the unique benefits of DAILIES TOTAL1® for Astigmatism Contact Lenses 
translate to improved functional vision and overall satisfaction for astigmatic patients. 
 
Objective: 
This study aims to assess the impact of DAILIES TOTAL1® for Astigmatism Contact Lenses on the 
functional vision of astigmatic patients as compared to DAILIES TOTAL1® Spherical Contact Lenses, 
using digital real-world and patient-reported outcome tools in Asian Eyes. 
 
Hypothesis: 
DAILIES TOTAL1® for Astigmatism Contact Lenses will improve both subjective and objective visual 
performance in astigmatic patients using digital devices compared to DAILIES TOTAL1® Spherical 
Contact Lenses in Asian Eyes. 
 
 
 

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Methodology 
Recruitment and Enrolment 
The study will involve adult participants aged between 18 and 39 years with -0.75 to -1.50 D of 
astigmatism. Potential participants will initially be screened for study eligibility by phone or in-person 
discussion. All subjects will consent before enrolment in the study. 
Inclusion Criteria: 
1. Asian (self-report and be confirmed by PI observation) 
2. Ages between 18 and 39 years 
3. Vertexed corrected sphere power between -0.50 and -6.00 D 
4. Vertexed refractive cylinder power between -0.75 and -1.50 D 
5. Best corrected acuity of 20/25 or better in each eye 
6. Habitual soft contact lens wearers at least 6 months (who should be successfully fitted with 
both DT1 Spherical and Toric contact lens) 
 
Exclusion Criteria: 
1. History of ocular pathology or surgery 
2. Active ocular infection or clinically significant ocular inflammation 
3. Any significant binocular vision abnormalities 
4. Wearers of gas-permeable lenses for at least 3 months prior to the study 
5. Pregnant or lactating individuals (by self-report) 
 
Study Design: 
This study will follow a double-masked randomized crossover design [10], where participants will be 
fitted with DAILIES TOTAL1® for Astigmatism and DAILIES TOTAL1® Spherical Contact Lenses in a 
randomized order. Each participant will use both types of lenses over different periods. The study 
will be composed of five visits: 
 

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Visit 1 - Baseline Evaluation and Fitting for Lens 1 
1. Obtain informed consent. 
2. Collect subject demographics, medical and ocular health, and information on concomitant 
medications. 
3. Measure binocular near logMAR visual acuity with the participant's habitual correction. 
4. Administer the Near Activity Visual Questionnaire (NAVQ) to gauge the participant's 
subjective experience of near vision function. [11] 
5. Evaluate the participant's reading performance, speed, and functionality with the MNREAD 
app. This will involve: 
i. 
Reading Acuity: Determine the smallest print size so that the participant can 
accurately read without making significant errors. The app will present sentences in 
various print sizes, starting from larger to smaller. 
ii. 
Critical Print Size: Identify the smallest print size that the participant can read at 
their fastest speed. This will be determined by observing the smallest print size read 
at the maximum speed by the participant. 
iii. 
Maximum Reading Speed: Assess by presenting sentences in a print size comfortable 
for the participant, then timing how long it takes for them to read these sentences. 
The reading speed will be computed in words per minute. 
iv. 
Reading Accessibility Index: Calculate this single-value measure, which represents a 
person's visual access to commonly encountered printed material, using data from 
the previous steps. 
6. Conduct manifest refraction using maximum plus to best visual acuity. 
7. Assess accommodation and binocular vision. 
8. Measure pupil size in dim and bright light settings. 
9. Complete an anterior segment slit lamp examination. 
10. After confirming eligibility, randomize and fit the subject with the first pair of contact lenses. 
11. Allow the contact lenses to settle for 10 minutes before evaluating the fit. 
12. Perform an over-refraction and adjust the lens power if necessary. 
 
Visit 2 - Contact Lens Follow-up 1 
1. Assess the subject who should be wearing the assigned study contact lenses for at least 2 
hours before the appointment. 
2. Perform an over-refraction and adjust the lens power if necessary. 
3. Conduct a slit lamp examination including ocular surface evaluation with sodium fluorescein 
after the contact lenses are removed. 
Visit 3 - Outcome Measures for Lens 1 and Fitting for Lens 2 
1. Have the subject report to the visit wearing their assigned study contact lenses for at least 2 
hours before their appointment. 
2. Administer the NAVQ. 
3. Conduct high-contrast, high-luminance visual acuity at 40 cm & 6 m and low-contrast, high-
luminance visual acuity at 6m 
4. Evaluate the participant's reading performance, speed, and functionality with the MNREAD 
app  

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5. Perform a slit lamp examination including sodium fluorescein after removing the study 
contact lenses. 
6. Fit the subject with the second pair of contact lenses based on the randomization schedule. 
7. Allow the contact lenses to settle for 10 minutes before evaluating. 
8. Perform an overrefraction and adjust the power of the alternate lenses if necessary. 
 
Visits 4 and 5 - Contact Lens Follow-up 2 and Outcome Measures for Lens 2 
1. Repeat the procedures from Visits 2 and 3 respectively for the second pair of lenses. 
 
Randomization: 
• 
Create a computer-generated list with 39 elements, each representing a type of lens (label 
"A" for DAILIES TOTAL1® for Astigmatism and "B" for DAILIES TOTAL1® Spherical Contact 
Lenses). 
• 
Shuffle the elements of the list to ensure random assignment. 
• 
Attach a coded sticker to each lens' blister packaging, corresponding to the codes in the 
computer-generated list. 
Note: Only a designated unmasked examiner, who does not interact directly with the 
participants or influence the data collection, interpretation, or analysis, will have access to the 
decoding key for these stickers. 
 
Visit 1: 
• 
After confirming eligibility, the unmasked examiner consults the randomization list and selects 
the appropriately coded package for the participant. 
• 
The unmasked examiner hands off the coded package to the masked examiner. 
• 
The masked examiner fits the subject with the first pair of lenses, without knowing the type 
of lens they are administering. 
 
Visit 3: 
• 
Repeat the process from Visit 1: the unmasked examiner, based on the randomization list, 
selects the second pair of lenses for the participant. 
• 
The unmasked examiner hands off the coded package to the masked examiner. 
• 
The masked examiner fits the subject with the second pair of lenses, maintaining the blindness 
of the study. 
 
End of Study: 
• 
At the end of the study, the unmasked examiner references the coding key to reveal the order 
in which the lenses were administered to each participant, allowing the research team to 
analyze the results accordingly. 
• 
This point form process ensures a robust double-blind crossover design, where the 
participants and the majority of the research team are not aware of the lens type being used 
at any point, reducing potential biases. 

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Endpoints: 
Primary Endpoints: 
1. Evaluate near (40cm) high-contrast visual acuity in logMAR by i-Pad‑based applications – 
EyeChart PRO 
 
Secondary Endpoints: 
1. Evaluate participant's reading acuity, critical print size, maximum reading speed, and reading 
accessibility index using the MNREAD app. Specifically: 
i. 
Reading Acuity: Identify the smallest print size that can be accurately read by the 
participant without significant errors. This is done by presenting sentences in 
decreasing print sizes. 
ii. 
Critical Print Size: Determine the smallest print size that the participant can read at 
their fastest reading speed. 
iii. 
Maximum Reading Speed: Measure by timing how long the participant takes to read 
sentences presented in a comfortable print size. The speed is calculated as words per 
minute. 
iv. 
Reading Accessibility Index: Compute this single-value metric, indicative of a person's 
visual access to commonly encountered printed text, using data from the previous 
steps. 
2. Evaluate the near visual function with the Near Activity Visual Questionnaire 
3. Distance high-low contrast visual acuity in logMAR by using E-ETDRS  (NIDEK SC-2000)  
 
 
Sample size justification 
1. The sample size for this study was calculated based on the results of a similar study [12] that 
assessed improvements in near high- and low-contrast visual acuity among astigmatic 
patients using toric contact lenses versus spherical contact lenses. 
2. The primary endpoint for our study is like the referenced study, and we expect a 1-line 
treatment benefit (0.1 logMAR) as the minimum clinically important difference. The within-
subject standard deviation of the outcome measure is also anticipated to be a line (0.1 
logMAR) based on the referenced study. 
3. To ensure adequate power for our study, set the significance level (α) at 0.05 (2-sided) and 
the power (1-β) at 0.80. Using these parameters and the formula for sample size calculation 
in a crossover design, we estimated a sample size of 35 participants. 
4. A dropout rate of approximately 10%. To ensure sufficient power to detect a statistically and 
clinically significant difference in our primary outcome, we plan to enrol 39 participants in 
this clinical trial. 
 
 
 

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Statical Analysis: 
The treatment effects will be analyzed using the Grizzle model for the two-period, two-treatment 
crossover trial [10]. The data will first be tested for the presence of a carryover effect according to the 
sequence of randomization, that is, sphere or toric, during the first period at the critical level of 0.10. 
Then, the treatment effect will be estimated using a linear mixed model in the presence of period and 
sequence effects to obtain unbiased effect sizes [10]. 
 
 
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Appendix 1: MNREAD testing sequence using the iPad app.  
(A) Preparation screen displayed before each sentence;  
(B) After the experimenter clicks the “GO” button, the first sentence is displayed in the center of the 
screen, launching the time recording;  
(C) Once the participant is done reading, a simple click will stop the trial and record the reading time. 
A score screen appears, allowing the experimenter to enter the number of errors and launch the 
next trial;  
(D) When reading becomes impossible, the test is stopped and the app displays the MNREAD data 
plot and parameter estimates. 
 
 
 
 

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Appendix 2: Near Activity Visual Questionnaire.