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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01467557
First received: October 26, 2011
Last updated: December 17, 2013
Last verified: December 2013
  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:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Incidence of adjudicated diagnosis adverse events [ Time Frame: From Baseline to 12 months ] [ Designated as safety issue: No ]
    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: From Baseline to 12 months ] [ Designated as safety issue: No ]
    Incidence rate (number) of infiltrative adverse events will be calculated and compared to historical rates at month 12


Enrollment: 1171
Study Start Date: October 2011
Study Completion Date: October 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 37 Study Locations
Sponsors and Collaborators
Vistakon
  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: December 17, 2013
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 August 28, 2014