Clinical Performance Comparison of Several Different Contact Lenses

NCT ID: NCT00912028

Last Updated: 2018-06-19

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-01

Study Completion Date

2010-02-01

Brief Summary

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The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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senofilcon A

contact lens

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

contact lens

lotrafilcon B

contact lens

Group Type ACTIVE_COMPARATOR

lotrafilcon B

Intervention Type DEVICE

contact lens

balafilcon A

contact lens

Group Type ACTIVE_COMPARATOR

balafilcon A

Intervention Type DEVICE

contact lens

methafilcon A

contact lens

Group Type ACTIVE_COMPARATOR

methafilcon A

Intervention Type DEVICE

contact lens

vifilcon A

contact lens

Group Type ACTIVE_COMPARATOR

vifilcon A

Intervention Type DEVICE

contact lens

Interventions

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senofilcon A

contact lens

Intervention Type DEVICE

lotrafilcon B

contact lens

Intervention Type DEVICE

balafilcon A

contact lens

Intervention Type DEVICE

methafilcon A

contact lens

Intervention Type DEVICE

vifilcon A

contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Subjects must:

* be existing soft contact lens wearers of the study control lenses
* require a distance visual correction in both eyes
* have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
* have astigmatism less than or equal to 1.00D in both eyes
* be able to wear lenses available for this study
* be corrected to a visual acuity of 6/9 (20/30) or better in each eye
* have normal eyes with no evidence of abnormality or disease

Exclusion Criteria

Subject are excluded for the following reasons:

* monovision corrected
* worn lenses extended wear in the last 3 months.
* require concurrent ocular medication
* grade 3 or 4 abnormalities
* grade 3 corneal staining in more than two regions
* anterior ocular surgery
* any other ocular surgery or injury within 8 weeks prior to study enrollment
* abnormal lachrymal secretions
* pre-existing ocular irritation that would preclude contact lens fitting
* corneal irregularities
* Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
* any systemic illness which would preclude contact lens wear
* diabetes
* infectious or immunosuppressive disease
* pregnancy or lactating, or planning pregnancy at time or enrollment
* participating in a concurrent clinical study or within last 60 days
* allergy to the standardized study care solution
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos E Leite Arieta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor - Ophthalmolgy, University of Campinas, Brazil

Locations

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Salvador, Estado de Bahia, Brazil

Site Status

Maringá, Paraná, Brazil

Site Status

Recife, Pernambuco, Brazil

Site Status

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Campinas, São Paulo, Brazil

Site Status

Marília, São Paulo, Brazil

Site Status

Ribeirão Preto, São Paulo, Brazil

Site Status

Santo André, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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AOH--BRA-001

Identifier Type: -

Identifier Source: org_study_id

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