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

NCT ID: NCT02103309

Last Updated: 2014-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-11-30

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.

Detailed Description

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Conditions

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Refractive Error Myopia Myopic Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DACP, then 1DAM

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.

Group Type OTHER

Nelfilcon A contact lenses

Intervention Type DEVICE

Etafilcon A contact lenses

Intervention Type DEVICE

1DAM, then DACP

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.

Group Type OTHER

Nelfilcon A contact lenses

Intervention Type DEVICE

Etafilcon A contact lenses

Intervention Type DEVICE

Interventions

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Nelfilcon A contact lenses

Intervention Type DEVICE

Etafilcon A contact lenses

Intervention Type DEVICE

Other Intervention Names

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DAILIES® AquaComfort® Plus DACP 1-DAY ACUVUE® MOIST®

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa L. Zoota, MPH, CCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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M-13-050

Identifier Type: -

Identifier Source: org_study_id

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