N/A
Completed N=99
Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population
Source: ClinicalTrials.gov NCT02710292 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear — 89.5; 47.4 percentage of subjects
Summary
The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear |
89.5; 47.4 | — |
Eligibility Criteria
Inclusion Criteria
- Must sign an informed consent form;
- Habitual current daily disposable soft contact lenses wearer;
- Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
- Lenses within the power range specified in the protocol;
- Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
- Acceptable lens fit with both study contact lenses;
- Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Currently wearing DT1 or TE sphere lenses;
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
- Eye injury or surgery within 12 weeks immediately prior to enrollment;
- History of herpetic keratitis, ocular surgery or irregular cornea;
- Prior refractive surgery;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Participation in any clinical trial within 30 days of the enrollment visit;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02710292). 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.