Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric
Phase: NA
Conditions: Astigmatism Bilateral
Sponsor: Ohio State University

 
 
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Evaluation of Wear Experience with Dailies TOTAL1® Contact 
lenses for Astigmatism and Biofinity® toric contact lenses 
Protocol number: 2022H0270 
NCT number: NCT05580575 
03 November 2022 
 
 
 
 
 
 
 
 
 

 
 
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Evaluation of Wear Experience with Dailies TOTAL1® Contact lenses for 
Astigmatism and Biofinity® toric contact lenses 
Jennifer Fogt, OD MS 
The Ohio State University College of Optometry 
Innovation in Vision and Eye care Research Group - iVERG 
338 West 10th Ave 
Columbus OH 43210 
Phone:  614-292-0882 
 
 
Purpose 
The purpose of this study is to explore the wear experience of current soft toric contact lens wearers after 
they have been fit into Dailies TOTAL1® Contact Lenses for Astigmatism and Biofinity Toric contact lenses.   
 
Study Overview 
This cross-over study compares the wear experience with Biofinity® toric contact lenses (Cooper Vision, 
San Ramon, CA, USA) to that of Dailies Total1® for Astigmatism contact lenses (Alcon, Fort Worth, TX, 
USA).  Each participant will wear each of the lenses for approximately 1 month.  Surveys will be completed 
of wear experience with each contact lens, and comparison surveys will be given at the end of the study.   
 
Background 
Soft daily wear contact lenses are used by an estimated 40.9 million adults in the United States.1  Contact 
lenses which are worn for daily wear are considered minimal risk by the FDA, and risks to wearers are 
minimized by proper lens care and hygiene. Daily disposable contact lenses do not require daily cleaning 
and overnight storage, which improves the required amount of time to care for contact lenses.  In 
addition, daily disposable contact lenses are associated with less lens deposits, which decreases 
associated comfort issues in lens wearers, including decreasing the risk of triggering Giant papillary 
conjunctivitis (GPC) and/or ocular allergic responses in patients.2  Additionally, daily disposable contact 
lens wearers are not likely to expose their lenses to water and tend to have better lens hygiene since these 
lenses do not require daily cleaning.  This is reflected in a study which found less superficial punctate 
staining and symptoms of dryness when comparing daily disposable contact lens wear with planned 
replacement lenses.3 The subjects in this study are current wearers of soft contact lenses for astigmatism.  
They will be fit with rewearable lenses (Biofinity®) and daily disposable lenses (Dailies TOTAL1 for 
Astigmatism).  Is it hypothesized that the daily disposable contact lenses, will have higher ratings for 
comfort based on the replacement schedule and the type of soft contact lens material. 
 
 

 
 
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Key Endpoints: 
• 
Subjective assessment of Biofinity Toric and Dailies TOTAL1 for astigmatism with CLDEQ-8  
• 
Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with both lenses 
• 
Assessment via questionnaire about quality of life, preference, and lens modality experience 
 
Study Time Points: 
Visit 1 will be conducted to consent the subject and determine eligibility.  Consenting will be conducted 
via phone call and REDCap and will occur before the subject arrives on site if possible.   The participant 
will verify their current soft contact lens prescription to ensure that their prescription falls in the 
prescription range available for both study lenses, and to make sure that the patient requires lenses for 
astigmatism in both eyes.  The participant will answer questions about ocular health to further determine 
eligibility. Upon reporting to the in-person portion of the visit, visual acuity and an evaluation of the 
subject’s ocular health will occur. Following a randomization table, either the Biofinity Toric or the Dailies 
TOTAL1 for Astigmatism will be fit at this visit. A survey of initial impression of the lens will be completed.  
Enough lenses will be dispensed to last 1 month (until the next visit).   
Visit 2: The participant will wear the study lenses to Visit 2, and will complete a VAS survey and the CLDEQ-
8 survey to assess their wear experience.  Visual acuity and lens fit, including lens rotation, will be 
assessed.  Participants will then be fit with the other study lens.  After a successful fit, the participant will 
complete an initial impressions survey.  
Visit 3: The participant will wear the study lenses to Visit 2, and will complete a VAS survey and the CLDEQ-
8 survey to assess their wear experience.  Visual acuity and lens fit, including lens rotation, will be 
assessed.  Subjects will then complete surveys about their lens wear experience and preference between 
the two study lenses. 
In the unlikely event that additional contact lenses are needed to properly optimize a contact lens fit, and 
additional follow-up visit may be scheduled after Visit 1 or Visit 2. 
 
Surveys will include:  
CLDEQ-8  
VAS survey of comfort/dryness/vision 
0-100 scale:  
Overall Quality of vision 
End of Day Quality of vision  
Overall comfort 
End of Day comfort 
Overall Satisfaction 
End of Day Satisfaction 
Overall dryness  
End of Day dryness 
 
Quality of life/preference, lens modality experience 

 
 
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Convenience of daily disposable, preference for daily disposable, ease of use 
Which lenses do you prefer based upon comfort? 
Which lenses do you prefer based upon vision? 
Which lenses do you prefer based on over-all performance? 
 
 
Recruitment 
Potential subjects may see posters placed on bulletin boards at The Ohio State University or local eye care 
offices, emails to students, faculty and staff at OSU, online or paper ads, or signs on the OSU buses.  A 
search of the electronic medical records of The Ohio State College of Optometry or a data base/records 
at the two off-campus sites may be done to identify possible subjects who then may be contacted by email 
or phone with information about the study. A search of The OSU College of Optometry Research Database 
(2017H0032) will also be completed.  Word of mouth referrals by study team members to OSU employees 
and friends may occur.  Emails to alumni of the OSU College of Optometry may be sent for local doctors 
to notify eligible potential subjects about the study.     
 
Inclusion criteria:  
 
Subjects must be current soft lens wearers in both eyes.    
 
Subjects must have 20/25 or better distance visual acuity with current lenses (entering 
acuity). 
 
Good general health (defined by medication use that has not changed within the last 
month and the absence of medical conditions or treatments that are deemed 
confounding to the data as determined by the PI) 
 
Ability to give informed consent  
 
Willing to spend time for the study.  Subjects will be required to attend two study visits 
and wear contact lenses on days between study visits.   
 
Either gender 
 
Any racial or ethnic origin 
Exclusion criteria:  
 
Participants cannot be pregnant or lactating. 
 
Participants cannot be current Biofinity Toric or Dailies TOTAL1 for Astigmatism wearers 
 
No current ocular inflammation or infection as assessed by the study investigator 
 
Consent and Confidentiality 
A team member trained in the consent process will provide the consent document for the potential 
subject to review in REDCap and will review the procedures with reference to the consent form by 
telephone if the potential participant has further questions. The participant is explicitly told that they may 
stop participation at any time. All subjects will have the capacity to give informed consent. If there is any 
doubt as to the subject’s ability to consent to the study, the subject will be excluded from the study. If the 

 
 
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subject agrees to take part in the screening or measurement, he or she will sign and date the consent 
form in REDCap. The subject will be provided with a copy of the consent form. 
The investigator team is trained in privacy issues and will be reminded of the importance of patient privacy 
prior to study initiation. Potential study participants will contact us after seeing advertisements, emails or 
hearing about the study by word of mouth, giving them the choice of whether or not they wish to 
participate in a study for people with dry eyes.  Privacy is protected by limiting information related to 
study recruitment only, and no other personal or medical information that should be private to the 
patients. The PHI needed is only for the purposes of this study. It is highly unlikely, indeed extremely 
remote that the dry eye symptoms or signs are related to private or personal information that should or 
would be preferred to be kept confidential to the patients. Risk factors for dry eye rarely relate to matters 
or conditions that would be personal to the patient such as personal relationships, behaviors or diseases 
that one prefers to keep private and confidential. 
 
Statistical Analysis and Power Calculation 
This small sample size of 70 was chosen for convenience, as this study is not intending to prove superiority, 
but to study the acceptability of the study lens in previous successful Biofinity® wearers.  
 
Data Management and Security 
During the active stages of the study (recruitment to last measurement visit), all paperwork for each 
subject will reside in a subject folder for easy access throughout the study. The folders will reside in the 
limited-access research area, in a locked file drawer or cupboard. At the completion of the study or 
disenrollment of a subject the paperwork in the subject’s folders will be reorganized into a regulatory 
binder and a data binder and will reside in an office in the limited-access research area. When the data 
analysis is completed and the study is considered complete, the binders will be stored in the secure 
Department or Office Clinical Research Area. Paperwork for individuals who participate in the baseline 
visit but are not eligible to continue the study will be stored in the study regulatory binder in an office in 
the limited-access research area. Any electronic data files that contain PHI, which is only needed for 
recruitment purposes, will be destroyed at the conclusion of the study.  PHI will not be accessed or created 
after participants are recruited and collected data will be used for research purposes only. All data must 
be kept for a minimum of five years per the OSU Office of Research’s data retention policy. 
 
Risks to Subjects and Mitigation 
Although rare, a subject could experience eye pain, changes in vision, continued redness or irritation of 
the eye when inserting or learning to insert a contact lens. More likely transient blurring of vision (less 
than one minute) or mild, transient (less than a minute) stinging may occur. 
 
 
 

 
 
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Adverse Events 
All adverse events will be documented and reported under the guidelines of The Ohio State University 
Event Reporting guidelines, with any serious, unanticipated and related events being reported to the IRB, 
by the PI, within 10 days. Adverse Events information will be summarized in the annual report to the IRB 
at the end of the study.  Adverse events will be assessed and determined by Dr. Jennifer Fogt.  
 
Subject Dismissal  
Subjects who, after study team member coaching, are not able to provide analyzable data may be 
dismissed from the study. Data may not be analyzable if a participant is unable able to utilize the 
examination room equipment, for example. These issues are usually revealed at the screening assessment 
visit. Subjects who cannot provide analyzable data will be dismissed for the study. Subjects who do not 
keep scheduled visits within the required time frame will be dismissed from the study. Study team 
members will make reasonable efforts to accommodate subjects’ schedules.  
 
Protocol Violations, Discontinuation  
In the event that a member of the study team or a representative of sponsor becomes aware of a major 
protocol violation, the IRB shall be notified within 10 working days.   
 
 
References 
 
1. 
Arita R, Mori N, Shirakawa R, et al. Meibum Color and Free Fatty Acid Composition in Patients 
With Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2015;56(8):4403-4412. 
2. 
Hickson-Curran S, Spyridon M, Hunt C, Young G. The use of daily disposable lenses in problematic 
reusable contact lens wearers. Cont Lens Anterior Eye. 2014;37(4):285-291. 
3. 
Ichijima H, Karino S, Sakata H, Cavanagh HD. Improvement of Subjective Symptoms and Eye 
Complications When Changing From 2-Week Frequent Replacement to Daily Disposable Contact 
Lenses in a Subscriber Membership System. Eye Contact Lens. 2016;42(3):190-195.