N/A
Completed N=47
DAILIES TOTAL1® Lens Centration in a Japanese Population
Source: ClinicalTrials.gov NCT02252133 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Success Rate of Lens Centration After 7 ± 2 Days of Wear — 100.0; 86.7 percentage of subjects
Summary
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate of Lens Centration After 7 ± 2 Days of Wear |
100.0; 86.7 | — |
Eligibility Criteria
Inclusion Criteria
- Sign Informed Consent document.
- Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
- Symptoms of contact lens discomfort as defined by protocol.
- Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
- Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
- Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
- Acceptable contact lens fit with both study contact lenses.
- Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Currently wearing DT1 or 1DAVTE.
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
- History of herpetic keratitis, ocular surgery or irregular cornea.
- Prior refractive surgery (e.g. LASIK, PRK, etc).
- Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
- Judged ineligible as a patient in this clinical study by the investigator.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02252133). 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. Informational only — not medical advice.