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| ID | Type | Description | Link |
|---|---|---|---|
| CTN# 155/2009 | Registry Identifier | Therapeutics Goods Aministration (TGA) |
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| Name | Class |
|---|---|
| Coles-Brennan Pty Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 | Other | Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental) |
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| Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL | Other | Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) |
|
| GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7 | Other | Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental) |
|
| Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3 | Other | Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galyfilcon A Habitual Lens | Device | Comparison of three soft contact lens designs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Lens Fit Characteristics | At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control):
| Approximately 40 minutes of wear time |
| Evaluation of Inter-Changeability | In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed:
After 30-40 minutes of settling time the following variables will be collected:
| Approximately 40 minutes of wear time |
| Determination of fit or Vision Differences | In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed:
After 30-40 minutes of settling time the following variables will be collected:
| Approximately 40 minutes of wear time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Brennan, McOptom PhD | Coles-Brennan Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coles-Brennan Pty Ltd | Hawthorn | Victoria | 3122 | Australia |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7 |
| Other |
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental) |
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| Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL | Other | Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) |
|
| Galyfilcon A 8.7 BC (Investigational) | Device | Comparison of three soft contact lens designs. |
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| Galyfilcon A 8.3 BC (Investigational) | Device | Comparison of three soft contact lens designs |
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