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

Not Applicable

Completed

Interventions: Device: Nelfilcon A contact lenses
Device: Etafilcon A contact lenses

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1DAM, then DACP	Etafilcon A contact lenses	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.
1DAM, then DACP	Nelfilcon A contact lenses	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.
DACP, then 1DAM	Etafilcon A contact lenses	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.
DACP, then 1DAM	Nelfilcon A contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Mean Investigator-Rated Lens Centration	After 1 week of wear	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.

Secondary Outcome Measures

Name	Time	Method
Average Subjective Ratings Score (Lens Handling and Overall Vision)	After 1 week of wear	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.
Mean Investigator-Rated Lens Fit	After 1 week of wear	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.
Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)	After 1 week of wear	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.