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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

NCT ID: NCT01634659

Last Updated: 2013-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

Detailed Description

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Conditions

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Myopia

Keywords

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contact lenses myopia

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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Delefilcon A, then narafilcon B

Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Group Type OTHER

Delefilcon A contact lenses (DAILIES TOTAL1®)

Intervention Type DEVICE

Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Intervention Type DEVICE

Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

Narafilcon B, then delefilcon A

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Group Type OTHER

Delefilcon A contact lenses (DAILIES TOTAL1®)

Intervention Type DEVICE

Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Intervention Type DEVICE

Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

Interventions

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Delefilcon A contact lenses (DAILIES TOTAL1®)

Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use

Intervention Type DEVICE

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Sign written Informed Consent Document and HIPAA form.
* Be current weekly/monthly replacement contact lens wearer.
* Be willing to not sleep in contact lenses during the study period.
* Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
* Have best corrected visual acuity of at least 20/25 in each eye.
* Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
* Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.

Exclusion Criteria

* Be a neophyte or current wearer of daily disposable lenses.
* Require monovision correction or use multifocal contact lenses.
* Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Have a history of ocular surgery/trauma within the last 6 months.
* Use topical ocular or systemic antibiotics within 7 days of enrollment.
* Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
* Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
* Use re-wetting drops once or more per day.
Minimum Eligible Age

18 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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Jami Kern, MBA, PhD

Role: STUDY_DIRECTOR

Alcon Research

Countries

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United States

Other Identifiers

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M-12-033

Identifier Type: -

Identifier Source: org_study_id