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Clinical Comparison of Two Daily Disposable Toric Lenses

NCT ID: NCT01362894

Last Updated: 2012-08-09

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Detailed Description

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This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Conditions

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Myopia Astigmatism

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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nelfilcon A / etafilcon A

Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Group Type OTHER

nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.

etafilcon A contact lens

Intervention Type DEVICE

Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.

etafilcon A / nelfilcon A

Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Group Type OTHER

nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.

etafilcon A contact lens

Intervention Type DEVICE

Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.

Interventions

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nelfilcon A contact lens

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.

Intervention Type DEVICE

etafilcon A contact lens

Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.

Intervention Type DEVICE

Other Intervention Names

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Focus® DAILIES® Toric 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM

Eligibility Criteria

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Inclusion Criteria

* Sign written informed consent.
* Germany: Be of legal age.
* Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.

Exclusion Criteria

* Eye injury or surgery within twelve weeks.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Wears contact lenses overnight while sleeping.
* Habitual daily disposable contact lens wearer.
* Monovision correction during the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P-346-C-013

Identifier Type: -

Identifier Source: org_study_id