Wear Experience With Daily Toric Contact Lenses Over a Long Day

Study Overview
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Brief Summary
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This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.

Official Title
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Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days

Conditions
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Contact Lens, Astigmatism of Both Eyes

Intervention / Treatment
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* Device: Precision1® Daily Disposable Toric Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available. Distance visual acuity of 20/25 or better with current lenses. Recent eye exam in the last year. 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. Must have a working smart phone or device and be willing to receive and respond to texts and/or emails. Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3. Exclusion Criteria: Current ocular inflammation or infection as assessed by the study investigator. Currently pregnant, lactating, or planning to become pregnant during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily Disposable Toric Contact Lens<br>All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks. | Device: Precision1® Daily Disposable Toric Contact Lens<br>* Soft, toric contact lens used to correct distance vision and astigmatism.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 1 describes poor experience, and 10 describes excellent experience. | Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear. | 
| Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 1 describes poor experience, and 10 describes excellent experience. | Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Daily Contact Lens, Toric Contact Lens