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

October 26, 2011
October 22, 2015
October 2011
October 2013   (final data collection date for primary outcome measure)
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.
  • 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
Complete list of historical versions of study NCT01467557 on ClinicalTrials.gov Archive Site
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).
  • 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 2 weeks of wear ] [ Designated as safety issue: No ]
    Number of subjects retained for 6 months within the lens brand at week 2
Not Provided
Not Provided
 
Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY
1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients who have recently been fit with 1-Day ACUVUE® TruEye™ or 1- Day ACUVUE® MOIST® daily disposable lenses.
  • Myopia
  • Hyperopia
  • Device: narafilcon B daily disposable soft contact lenses
    daily disposable soft contact lenses
    Other Name: 1-Day ACUVUE TruEye
  • Device: etafilcon A daily disposable soft contact lenses
    daily disposable soft contact lenses
    Other Name: 1-Day ACUVUE MOIST
  • 1-Day ACUVUE TruEye contact lens users
    1-Day ACUVUE TruEye contact lens users
    Intervention: Device: narafilcon B daily disposable soft contact lenses
  • 1-Day ACUVUE MOIST contact lens users
    1-Day ACUVUE MOIST contact lens users
    Intervention: Device: etafilcon A daily disposable soft contact lenses
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1171
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
8 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01467557
CR-005059
No
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP