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
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 April 17, 2014