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

Completed

• Conditions: Hyperopia; Myopia
• Interventions: Device: etafilcon A daily disposable soft contact lenses; Device: narafilcon B daily disposable soft contact lenses

• Registration Number: NCT01467557
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2015-07-01
• Results First Submitted QC: 2015-08-12
• Results First Posted: 2015-09-15
• Status Verified: 2015-10
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1171

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1-Day ACUVUE MOIST contact lens users	etafilcon A daily disposable soft contact lenses	1-Day ACUVUE MOIST contact lens users
1-Day ACUVUE TruEye contact lens users	narafilcon B daily disposable soft contact lenses	1-Day ACUVUE TruEye contact lens users

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	Self-report at 2 Week, 4 Month or 12 Month surveys	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.

Secondary Outcome Measures

Name	Time	Method
Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys	Baseline, 2 Week, 4 Month or 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).