Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

Study Overview
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Brief Summary
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The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.

Official Title
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Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®

Conditions
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Refractive Error, Myopia, Myopic Astigmatism

Intervention / Treatment
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* Device: Nelfilcon A contact lenses
* Device: Etafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20 Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week Those who play ball sports at least 1 day per week Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction Other protocol-defined inclusion criteria may apply Exclusion Criteria: Those who regularly wear the study device Those who require ocular treatment with eye drops Those who have a condition contraindicating soft contact lens wear, such as eye irritation Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study Those who are participating in another clinical study or research or have a plan of such participation during the present study Women who are pregnant or intend to become pregnant during the study Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 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: DACP, then 1DAM<br>Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. | Device: Nelfilcon A contact lenses<br> <br> * Other names: DACP;Device: Etafilcon A contact lenses<br> <br> * Other names: 1-DAY ACUVUE® MOIST®;|
| Other: 1DAM, then DACP<br>Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode. | Device: Nelfilcon A contact lenses<br> <br> * Other names: DACP;Device: Etafilcon A contact lenses<br> <br> * Other names: 1-DAY ACUVUE® MOIST®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Investigator-Rated Lens Centration | Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean. | After 1 week of wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Investigator-Rated Lens Fit | Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean. | After 1 week of wear | 
| Average Subjective Ratings Score (Lens Handling and Overall Vision) | The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean. | After 1 week of wear | 
| Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) | The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. Overall Vision was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean. | After 1 week of wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft contact lenses, DACP