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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Delefilcon A contact lenses
* Device: Narafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DT1, then TE<br>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. | Device: Delefilcon A contact lenses<br> <br> * Other names: DT1;Device: Narafilcon A contact lenses<br> <br> * Other names: 1-DAY ACUVUE® TruEye®;|
| Other: TE, then DT1<br>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. | Device: Delefilcon A contact lenses<br> <br> * Other names: DT1;Device: Narafilcon A contact lenses<br> <br> * Other names: 1-DAY ACUVUE® TruEye®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Investigator-rated Lens Centration of Optimal After 10 Days of Wear | 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. | Day 10, each product |