Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

NCT ID: NCT01054807

Last Updated: 2018-06-19

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

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-01

Study Completion Date

2010-03-01

Brief Summary

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The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3

Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)

Group Type OTHER

Galyfilcon A Habitual Lens

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.7 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.3 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs

Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL

Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Group Type OTHER

Galyfilcon A Habitual Lens

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.7 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.3 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs

GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7

Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)

Group Type OTHER

Galyfilcon A Habitual Lens

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.7 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.3 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs

Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3

Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)

Group Type OTHER

Galyfilcon A Habitual Lens

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.7 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.3 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs

Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7

Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)

Group Type OTHER

Galyfilcon A Habitual Lens

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.7 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.3 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs

Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL

Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Group Type OTHER

Galyfilcon A Habitual Lens

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.7 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs.

Galyfilcon A 8.3 BC (Investigational)

Intervention Type DEVICE

Comparison of three soft contact lens designs

Interventions

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Galyfilcon A Habitual Lens

Comparison of three soft contact lens designs.

Intervention Type DEVICE

Galyfilcon A 8.7 BC (Investigational)

Comparison of three soft contact lens designs.

Intervention Type DEVICE

Galyfilcon A 8.3 BC (Investigational)

Comparison of three soft contact lens designs

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be of legal age (i.e., at least 18 years old)
* Sign a written informed consent
* Have contact lens distance sphere requirement in the range -1.00D to -6.00D
* Have spectacle astigmatism \<1.25D in each eye
* Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
* Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria

* Required concurrent ocular medication
* Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial
* Known allergy to silver, silver ions, or silver containing compounds.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coles-Brennan Pty Ltd

UNKNOWN

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noel Brennan, McOptom PhD

Role: PRINCIPAL_INVESTIGATOR

Coles-Brennan Pty Ltd

Locations

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Coles-Brennan Pty Ltd

Hawthorn, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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CTN# 155/2009

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR-0915

Identifier Type: -

Identifier Source: org_study_id

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