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

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

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 Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Device: narafilcon B daily disposable soft contact lenses; Device: etafilcon A daily disposable soft contact lenses

• Study Type: Observational
• Enrollment (Actual): 1171

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
    • Fullerton, California, United States, 92831-1615
    • Huntington Beach, California, United States, 92647
    • Los Angeles, California, United States, 90049
    • Mountain View, California, United States, 94041
    • Newport Beach, California, United States, 92660
    • Salinas, California, United States, 93901
    • San Francisco, California, United States, 94103
    • San Francisco, California, United States, 94158
    • San Francisco, California, United States, 94111
    • San Jose, California, United States, 95131
    • Sunnyvale, California, United States, 94086
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
  • Florida
    • Boca Raton, Florida, United States, 33431-7253
    • Boca Raton, Florida, United States, 33432-3938
    • Fort Lauderdale, Florida, United States, 33316
    • Fort Lauderdale, Florida, United States, 33328-2018
    • North Miami, Florida, United States, 33181
    • Pembroke Pines, Florida, United States, 33024
    • Wellington, Florida, United States, 33414
  • Georgia
    • Roswell, Georgia, United States, 30075
  • Iowa
    • Des Moines, Iowa, United States, 50310
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
    • Cambridge, Massachusetts, United States, 02138
    • Dedham, Massachusetts, United States, 02026
  • New Jersey
    • Lake Hopatcong, New Jersey, United States, 07849
  • New York
    • New York, New York, United States, 10022
    • New York, New York, United States, 10036
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
    • Gastonia, North Carolina, United States, 28054
  • Ohio
    • Cleveland, Ohio, United States, 43081
    • Johnstown, Ohio, United States, 43031
    • Westerville, Ohio, United States, 43081
  • Tennessee
    • Brentwood, Tennessee, United States, 37027-7552
  • Texas
    • Amarillo, Texas, United States, 79119
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53227

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have recently been fit with 1-Day ACUVUE® TruEye™ or 1- Day ACUVUE® MOIST® daily disposable lenses.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1-Day ACUVUE TruEye contact lens users	Device: narafilcon B daily disposable soft contact lenses; daily disposable soft contact lenses; Other Names: 1-Day ACUVUE TruEye
1-Day ACUVUE MOIST contact lens users	Device: etafilcon A daily disposable soft contact lenses; daily disposable soft contact lenses; Other Names: 1-Day ACUVUE MOIST

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Publications and helpful links

General Publications

• Hickson-Curran SB, Chalmers RL, Keay L, Gleason W. Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry. Eye Contact Lens. 2017 Sep;43(5):313-317. doi: 10.1097/ICL.0000000000000271.
• Chalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: adverse events
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CR-005059