Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-12-31

Brief Summary

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The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24 months.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Silicone hydrogel contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Has had an oculo-visual examination in the last 2 years.
* Is correctable to at least 6/7.5 distance visual acuity in each eye with spherical contact lenses.
* Is a current soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No