Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

NCT ID: NCT01561560

Last Updated: 2014-01-07

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

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DAILIES TOTAL1, then TRUEYE

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

Group Type OTHER

Delefilcon A contact lenses

Intervention Type DEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Narafilcon A contact lenses

Intervention Type DEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

TRUEYE, then DAILIES TOTAL1

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

Group Type OTHER

Delefilcon A contact lenses

Intervention Type DEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Narafilcon A contact lenses

Intervention Type DEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Interventions

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Delefilcon A contact lenses

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Intervention Type DEVICE

Narafilcon A contact lenses

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

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 written Informed Consent Document.
* Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
* Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
* Willing to wear study lenses for at least eight hours per day and at least five days per week.

Exclusion Criteria

* Has not worn contact lenses before.
* Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
* Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
* Ocular surgery/trauma within the last six months.
* Topical ocular or systemic use of antibiotics within seven days of enrollment.
* Pregnant or nursing women.
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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Camille Girault

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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P-347-C-019

Identifier Type: -

Identifier Source: org_study_id

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