Total30 for Astigmatism Contact Lenses

Study Overview
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Brief Summary
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Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

Detailed Description
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A common issues that contact lens (CL) wearers frequently face is that their discomfort symptoms increase towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 for Astigmatism CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 for Astigmatism CLs. These data are not only important for judging the performance of Total30 for Astigmatism CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

Official Title
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How Does Total30 for Astigmatism Perform During a Long Day of Wear?

Conditions
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Astigmatism, Contact Lens Complication, Refractive Errors

Intervention / Treatment
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* Device: TOTAL30 for Astigmatism Contact Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18- to 45-year-old Visual acuity 20/20 or better Contact Lens Dry Eye Questionnaire [CLDEQ]-8 scores <10 Willing to wear Total30 for Astigmatism CLs Have a smart phone with text messaging capabilities Astigmatism ranging from 0.75 D to 2.50 D in each eye Regularly worn 2 week or monthly CLs within the past 6 months Current CL wearer Glasses prescription that is less than 2 years old Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected Exclusion Criteria: Current or past hard CL wearers A known systemic health condition that is thought to alter tear film physiology A history of viral eye disease A history of ocular surgery A history of severe ocular trauma Have an active ocular infection or inflammation Currently using isotretinoin-derivatives or ocular medications Currently using rewetting drops or artificial tears Pregnant or breast feeding Willing to discontinue usage of current toric CLs one week prior to the initial visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism Contact Lenses.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total30 for Astigmatism Contact Lenses<br>TOTAL30 for Astigmatism Monthly Replacement Contact Lenses | Device: TOTAL30 for Astigmatism Contact Lenses<br>* Participants will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.<br>* Other names: Lehfilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Comfort Scores | A VAS will be used to compare end of day ocular comfort at about 16 hours of contact lens wear (± 50 scale with +50 being best possible comfort and -50 being worst possible comfort). | Change from baseline at 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens, TOTAL30 for Astigmatism, Comfort, Dryness, Visual Analog Scale