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Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

NCT ID: NCT00933166

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

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.

Detailed Description

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Conditions

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Myopia

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 A

Investigational contact lens worn in both eyes for three months

Group Type EXPERIMENTAL

Lotrafilcon A contact lens

Intervention Type DEVICE

Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months

Interventions

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Lotrafilcon A contact lens

Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
* Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
* Be able to wear the study lenses in the available powers.
* Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.

Exclusion Criteria

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* History of corneal refractive surgery.
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-335-C-014v2

Identifier Type: -

Identifier Source: org_study_id