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

Johnson & Johnson Vision Care, Inc.1,171 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,171

Conditions

Myopia Hyperopia

Interventions

narafilcon B daily disposable soft contact lensesDEVICE

daily disposable soft contact lenses

etafilcon A daily disposable soft contact lensesDEVICE

daily disposable soft contact lenses

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

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.

Time frame: Self-report at 2 Week, 4 Month or 12 Month surveys

Secondary Outcomes

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).

Time frame: Baseline, 2 Week, 4 Month or 12 Month surveys

Data from ClinicalTrials.gov

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Campbell, California, United States

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Fullerton, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Mountain View, California, United States

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Newport Beach, California, United States

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Salinas, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

...and 27 more locations