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Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

NCT ID: NCT01007916

Last Updated: 2012-07-10

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

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

Participants

Study Groups

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Lotrafilcon B / Habitual

Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.

Group Type OTHER

Lotrafilcon B contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.

Habitual contact lens

Intervention Type DEVICE

Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.

Habitual / Lotrafilcon B

Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.

Group Type OTHER

Lotrafilcon B contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.

Habitual contact lens

Intervention Type DEVICE

Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.

Interventions

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Lotrafilcon B contact lens

Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.

Intervention Type DEVICE

Habitual contact lens

Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
* Wears lenses at least 5 days per week and at least 12 hours per day.
* Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
* Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
* Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
* Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.

Exclusion Criteria

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Currently sleeping in contact lenses for more than 6 consecutive nights.
* Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
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

Countries

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United States

Other Identifiers

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P-336-C-016

Identifier Type: -

Identifier Source: org_study_id