Clinical trial NCT01467557: Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY
Official title: 1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Hyperopia
Keywords: adverse events
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 1171
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Self-report at 2 Week, 4 Month or 12 Month surveys
Secondary outcomes:
measure: Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys
timeFrame: Baseline, 2 Week, 4 Month or 12 Month surveys
Other outcomes:
Locations:
city: Campbell
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Jose
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Boca Raton
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Des Moines
country: United States
state: Iowa
city: Shreveport
country: United States
state: Louisiana
city: Belmont
country: United States
state: Massachusetts
city: Cambridge
country: United States
state: Massachusetts
city: Dedham
country: United States
state: Massachusetts
city: Lake Hopatcong
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Gastonia
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Johnstown
country: United States
state: Ohio
city: Westerville
country: United States
state: Ohio
city: Brentwood
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References:
citation: 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.
citation: 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.