Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

NCT ID: NCT01548833

Last Updated: 2013-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable 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

SINGLE

Investigators

Study Groups

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Dailies Total 1

Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Group Type EXPERIMENTAL

Delefilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Narafilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Filcon II 3 contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear

TruEye

Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Group Type ACTIVE_COMPARATOR

Delefilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Narafilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Filcon II 3 contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear

Clariti

Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Group Type ACTIVE_COMPARATOR

Delefilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Narafilcon A contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Filcon II 3 contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens for single use, daily disposable wear

Interventions

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Delefilcon A contact lens

Silicone hydrogel contact lens for single use, daily disposable wear.

Intervention Type DEVICE

Narafilcon A contact lens

Silicone hydrogel contact lens for single use, daily disposable wear.

Intervention Type DEVICE

Filcon II 3 contact lens

Silicone hydrogel contact lens for single use, daily disposable wear

Intervention Type DEVICE

Other Intervention Names

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DAILIES® TOTAL1™ 1-DAY ACUVUE® TRUEYE™ Clariti™ 1-day

Eligibility Criteria

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Inclusion Criteria

* Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
* Require vision correction in both eyes.
* Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
* Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
* Willing and able to wear study contact lenses 16 hours per day.
* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.

Exclusion Criteria

* Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
* Require monovision correction.
* Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Ocular surgery/trauma within the last 6 months.
* Topical or systemic antibiotic use within 7 days of enrollment.
* Topical ocular or systemic corticosteroid use within 14 days of enrollment.
* Pregnant and nursing women.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aston University

OTHER

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jami Kern, PhD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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A00924

Identifier Type: -

Identifier Source: org_study_id

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