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

Alcon

Status: Completed

Conditions: Myopia; Refractive Error; Myopic Astigmatism

Treatments: Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02103309

M-13-050

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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42 participants in 2 patient groups

DACP, then 1DAM

Other group

Description:

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.

Treatment:

Device: Etafilcon A contact lenses

Device: Nelfilcon A contact lenses

1DAM, then DACP

Other group

Description:

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.

Treatment:

Device: Etafilcon A contact lenses

Device: Nelfilcon A contact lenses