Clinical Evaluation of a Silicone Hydrogel Lens

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

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

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

DOUBLE

Participants Investigators

Interventions

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lotrafilcon A contact lens

Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
* Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
* Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.

Exclusion Criteria

* Eye injury or surgery within 12 months prior to enrollment.
* Currently enrolled in any clinical trial.
* History of corneal refractive surgery.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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P-019-C-055

Identifier Type: -

Identifier Source: org_study_id