Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers

Study Overview
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Brief Summary
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To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients.

Detailed Description
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This study is a single site, prospective, subject-masked, observational study of the subjective performance of DT1fA in symptomatic patients. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.

Official Title
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Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers

Conditions
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Astigmatism

Intervention / Treatment
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* Device: DT1fA


Participation Criteria
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Eligibility Criteria
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Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Inclusion Criteria: Willing and able to provide informed consent Adult (18-38 years of age) Adapted and optimized current reusable soft toric lens wearer who has at least 3 months of wearing experience, and typically wears lenses every day, or at least 5 days per week, ≥10 hours per day Prescription needs with sphere and cylinder values that can be appropriately fit with current available parameters in the Dailies Total1® Contact lenses for Astigmatism product line Vision correctable to 20/25 Snellen (0.1 logMAR) or better in each eye at 6m Willing to wear lenses every day or at least 5 days per week, 10 or more hours per day and attend all study visits and follow instructions CLDEQ-8 minimum score of 12 Exclusion Criteria: If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. Ocular anterior segment infection, inflammation, abnormality, or active disease including diagnosed dry eye, that would contraindicate contact lens wear Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator Monocular (only 1 eye with functional vision) or fit with only 1 lens Fitted with monovision Prior Refractive Surgery History of herpetic keratitis, ocular surgery, or irregular cornea Pregnant or lactating The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bilateral use of DT1fA contact lenses<br>DT1fA contact lenses | Device: DT1fA<br>* DT1fA contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLDEQ-8 Questionnaire Score |  | two weeks after refit |