Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY

Study Overview
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Brief Summary
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This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.

Official Title
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1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* Device: narafilcon B daily disposable soft contact lenses
* Device: etafilcon A daily disposable soft contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wearers of 1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® daily disposable soft contact lenses in both eyes aged >8 years of age who have recently begun use of that lens type and have purchased at least 3 month supply of lenses. The registrant must read and sign the Informed Consent form. Minor subjects must obtain parental signature of Informed Consent and also sign an Informed Assent Form. The registrant must sign the Release of Medical Records in the event of an adverse event in the study. The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Previously wearing the type of lenses with which they are registering (1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® Daily Disposable lenses). Current participant in an unrelated research study. Employee or family member of Recruiting Practitioner or Johnson & Johnson.

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-Day ACUVUE TruEye contact lens users<br>1-Day ACUVUE TruEye contact lens users | Device: narafilcon B daily disposable soft contact lenses<br>* daily disposable soft contact lenses<br>* Other names: 1-Day ACUVUE TruEye;|
| 1-Day ACUVUE MOIST contact lens users<br>1-Day ACUVUE MOIST contact lens users | Device: etafilcon A daily disposable soft contact lenses<br>* daily disposable soft contact lenses<br>* Other names: 1-Day ACUVUE MOIST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Adverse events were reported by subjects via the electronic surveys if they responded yes to the question Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?. Consensus diagnosis was made after review of clinical records by Adjudication Panel. | Self-report at 2 Week, 4 Month or 12 Month surveys | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys | The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous). | Baseline, 2 Week, 4 Month or 12 Month surveys | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adverse events