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

Myopia Clinical Trial

— TEMPO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467557
• Other study ID #: CR-005059
• Status: Completed
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1171
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• narafilcon B daily disposable soft contact lenses
daily disposable soft contact lenses
• etafilcon A daily disposable soft contact lenses
daily disposable soft contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	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.	Self-report at 2 Week, 4 Month or 12 Month surveys
Secondary	Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys	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).	Baseline, 2 Week, 4 Month or 12 Month surveys