Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
NCT ID: NCT01054807
Last Updated: 2018-06-19
Study Results
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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COMPLETED
NA
32 participants
INTERVENTIONAL
2009-11-01
2010-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
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)
Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)
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)
Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)
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)
Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)
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)
Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)
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)
Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)
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)
Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)
Comparison of three soft contact lens designs
Interventions
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Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)
Comparison of three soft contact lens designs
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Coles-Brennan Pty Ltd
UNKNOWN
Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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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
Countries
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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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