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Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

NCT ID: NCT01268501

Last Updated: 2012-06-29

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

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Detailed Description

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Conditions

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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 multifocal

Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Group Type EXPERIMENTAL

Lotrafilcon B multifocal contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.

Interventions

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Lotrafilcon B multifocal contact lens

Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® AQUA MULTIFOCAL

Eligibility Criteria

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Inclusion Criteria

* Is between 40 and 48 years of age (inclusive).
* Has read and signed the Informed Consent.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Wears reading spectacles for close work.

Exclusion Criteria

* Eye injury or surgery within twelve weeks of enrollment.
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
* Currently enrolled in a clinical trial.
* Has worn contact lenses previously.
Minimum Eligible Age

40 Years

Maximum Eligible Age

48 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-319-C-019

Identifier Type: -

Identifier Source: org_study_id