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DAILIES TOTAL1® Lens Centration in a Japanese Population

NCT ID: NCT02252133

Last Updated: 2016-01-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

Detailed Description

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Conditions

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Myopia Refractive Error

Keywords

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Contact lenses Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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DT1, then 1DAVTE

Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.

Group Type OTHER

Delefilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Narafilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear

1DAVTE, then DT1

Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.

Group Type OTHER

Delefilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Narafilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Interventions

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Delefilcon A contact lenses

Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Intervention Type DEVICE

Narafilcon A contact lenses

Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Intervention Type DEVICE

Other Intervention Names

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DAILIES TOTAL1® 1-DAY ACUVUE® TruEye®

Eligibility Criteria

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Inclusion Criteria

* Sign Informed Consent document.
* Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
* Symptoms of contact lens discomfort as defined by protocol.
* Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
* Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
* Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
* Acceptable contact lens fit with both study contact lenses.
* Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.

Exclusion Criteria

* Currently wearing DT1 or 1DAVTE.
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
* History of herpetic keratitis, ocular surgery or irregular cornea.
* Prior refractive surgery (e.g. LASIK, PRK, etc).
* Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
* Judged ineligible as a patient in this clinical study by the investigator.
Minimum Eligible Age

20 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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Senior Manager, Clinical Development

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

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Contact Alcon Japan Ltd. for Trial Locations

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ALJ-V2014-1

Identifier Type: -

Identifier Source: org_study_id