Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

Not Applicable

Completed

Interventions: Device: Delefilcon A contact lenses
Device: Narafilcon A contact lenses

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
TE, then DT1	Narafilcon A contact lenses	Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
DT1, then TE	Narafilcon A contact lenses	Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
DT1, then TE	Delefilcon A contact lenses	Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
TE, then DT1	Delefilcon A contact lenses	Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear	Day 10, each product	Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.

Secondary Outcome Measures