N/A
N=1,171
Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY
Myopia · Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT01467557 ↗Enrolled (actual)
1,171
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Incidence of Adverse Events — 2; 0; 8; 3 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- narafilcon B daily disposable soft contact lenses (Device); etafilcon A daily disposable soft contact lenses (Device)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
2; 0; 8; 3; 5; 2 | — |
| SECONDARY Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys |
12.8; 12.3; 7.3; 8.0; 8.7; 9.3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01467557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.