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

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.

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Key information

Conditions

Myopia Eye Diseases Hyperopia Refractive Errors

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Campbell, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

narafilcon B daily disposable soft contact lenses

Device

daily disposable soft contact lenses

Other names: 1-Day ACUVUE TruEye

etafilcon A daily disposable soft contact lenses

Device

daily disposable soft contact lenses

Other names: 1-Day ACUVUE MOIST

Primary outcomes

Incidence of Adverse Events

Time frame: Self-report at 2 Week, 4 Month or 12 Month surveys

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 outcomes

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

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).

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study 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

Acronym: TEMPO

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Nov 8, 2011
Registry last updated: Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed