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Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

NCT ID: NCT01293240

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

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

Detailed Description

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Conditions

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Myopia Astigmatism Presbyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lotrafilcon B

Group Type EXPERIMENTAL

lotrafilcon B contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.

Interventions

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lotrafilcon B contact lens

Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL

Eligibility Criteria

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Inclusion Criteria

* Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
* Good general health.
* Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
* Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.

Exclusion Criteria

* Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
* Administration of any investigational drug or device within 14 days of study initiation.
* Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
* Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
* Post-refractive surgery.
* Currently pregnant or lactating by case history.
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-368-C-400

Identifier Type: -

Identifier Source: org_study_id