Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01467557
First received: October 26, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Myopia
Hyperopia
 Device: narafilcon B daily disposable soft contact lenses
Device: etafilcon A daily disposable soft contact lenses

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Incidence of adjudicated diagnosis adverse events [ Time Frame: after 12 months of wear ] [ Designated as safety issue: Yes ]
    Incidence rate (number) of adjudicated diagnosis adverse events will be calculated and compared to historical rates at month 12

  • Incidence of infiltrative adverse events [ Time Frame: after 12 months of wear ] [ Designated as safety issue: Yes ]
    Incidence rate (number) of infiltrative adverse events will be calculated and compared to historical rates at month 12


Secondary Outcome Measures:
  • Subjective contact-lens related eye dryness [ Time Frame: after 2 weeks of wear ] [ Designated as safety issue: No ]
    Scored Contact Lens Dry Eye Questionnaire (CLDEQ-8) at week 2

  • Subjective overall opinion of contact lenses: [ Time Frame: after 2 weeks of wear ] [ Designated as safety issue: No ]
    Scored Contact Lens Dry Eye Questionnaire (CLDEQ-8) at week 2

  • Contact lens wearer retention [ Time Frame: after 12 months of wear ] [ Designated as safety issue: No ]
    Number of subjects retained for 12 months within the lens brand


Estimated Enrollment: 1250
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1-Day ACUVUE TruEye contact lens users
1-Day ACUVUE TruEye contact lens users
 Device: narafilcon B daily disposable soft contact lenses
daily disposable soft contact lenses
Other Name: 1-Day ACUVUE TruEye
1-Day ACUVUE MOIST contact lens users
1-Day ACUVUE MOIST contact lens users
 Device: etafilcon A daily disposable soft contact lenses
daily disposable soft contact lenses
Other Name: 1-Day ACUVUE MOIST

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467557

  Hide Study Locations
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, 94158
San Francisco, California, United States, 94111
San Francisco, California, United States, 94103
San Jose, California, United States, 95131
Sunnyvale, California, United States, 94086
United States, District of Columbia
Washington, District of Columbia, United States, 20016
United States, Florida
Boca Raton, Florida, United States, 33431-7253
Boca Raton, Florida, United States, 33432-3938
Fort Lauderdale, Florida, United States, 33328-2018
Fort Lauderdale, Florida, United States, 33316
North Miami, Florida, United States, 33181
Pembroke Pines, Florida, United States, 33024
Wellington, Florida, United States, 33414
United States, Georgia
Roswell, Georgia, United States, 30075
United States, Iowa
Des Moines, Iowa, United States, 50310
United States, Louisiana
Shreveport, Louisiana, United States, 71105
United States, Massachusetts
Belmont, Massachusetts, United States, 02478
Cambridge, Massachusetts, United States, 02138
Dedham, Massachusetts, United States, 02026
United States, New Jersey
Lake Hopatcong, New Jersey, United States, 07849
United States, New York
New York, New York, United States, 10022
New York, New York, United States, 10036
United States, North Carolina
Charlotte, North Carolina, United States, 28210
Gastonia, North Carolina, United States, 28054
United States, Ohio
Cleveland, Ohio, United States, 43081
Johnstown, Ohio, United States, 43031
Westerville, Ohio, United States, 43081
United States, Tennessee
Brentwood, Tennessee, United States, 37027-7552
United States, Texas
Amarillo, Texas, United States, 79119
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53227
Sponsors and Collaborators
Vistakon
Investigators
Principal Investigator: Robin L. Chalmers, OD Clinical Trial Consultant
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01467557     History of Changes
Other Study ID Numbers: CR-005059
Study First Received: October 26, 2011
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vistakon:
adverse events

Additional relevant MeSH terms:
Hyperopia
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013