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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):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01467557
First received: October 26, 2011
Last updated: October 22, 2015
Last verified: October 2015
  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 Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Self-report at 2 Week, 4 Month or 12 Month surveys ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys [ Time Frame: Baseline, 2 Week, 4 Month or 12 Month surveys ] [ Designated as safety issue: No ]
    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).


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   (Child, Adult, Senior)
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
Johnson & Johnson Vision Care, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01467557     History of Changes
Other Study ID Numbers: CR-005059 
Study First Received: October 26, 2011
Results First Received: July 1, 2015
Last Updated: October 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Vision Care, Inc.:
adverse events

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on December 09, 2016