Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

Study Overview
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Brief Summary
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Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

Detailed Description
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This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)

Official Title
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A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Control
* Device: Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent. Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations. Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas. Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. Exclusion Criteria: Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months. Subject has systemic disease affecting ocular health. Subject is using any systemic or topical medications that will affect ocular physiology or lens performance. Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications. Subject has any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Soft Contact Lens | Device: Test<br>* Soft Contact Lens<br>|
| Active Comparator: Control<br>Contact lens | Device: Control<br>* Contact Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better | The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes | Evaluated at the 1 week follow up visit |