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The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 2 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 3 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 4 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galyfilcon A | Device | contact lenses worn bilaterally for 8-12 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Corneal Swelling | measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm) | after 8 hours of lens wear |
| Limbal Redness | grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade. | after 8 hours of lens wear |
| Endothelia Blebs | 0 to 100% of area; measured as a percentage of corneal area with blebs. | after 20 minutes of lens wear |
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Inclusion Criteria:
Be of legal age (i.e. 18 years)
Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)
Be mentally competent, willing and able to sign a written informed consent form.
Have contact lens distance sphere requirement in the range 1.00D to 6.00D.
Have spectacle astigmatism <1.25D in each eye
Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications
Have had an oculo-visual examination within the previous 12 months.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawthorn | Victoria | 3122 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects who were screened, gave consent, enrolled, and were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Corneal Swelling | measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm) | Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured. | Posted | Mean | Standard Deviation | microns | after 8 hours of lens wear | eyes | eyes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daria Wicks, Senior Clinical Research Manager | Johnson & Johnson Vision Care | 904-443-1391 | RA-ClnclStds@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Sequence 5 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 6 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 7 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 8 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 9 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| Sequence 10 | Other | Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
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| galyfilcon A plus | Device | contact lenses worn bilaterally for 8-12 hours |
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| lotrafilcon A | Device | contact lenses worn bilaterally for 8-12 hours |
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| polymacon | Device | contact lenses worn bilaterally for 8-12 hours |
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| spectacles | Other | habitual spectacles owned by subject, non-specific manufacturer |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| OG002 |
| Galyfilcon A |
test article |
| OG003 | Lotrafilcon A | test article |
| OG004 | Polymacon | test article |
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| Primary | Limbal Redness | grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade. | Subjects who were enrolled, randomized, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | after 8 hours of lens wear | eyes | eyes |
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| Primary | Endothelia Blebs | 0 to 100% of area; measured as a percentage of corneal area with blebs. | Subjects who were enrolled, randomized and completed the study. | Posted | Mean | Standard Deviation | percentage of area | after 20 minutes of lens wear | eyes | eyes |
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| 0 |
| 21 |
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| 21 |
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| eyes |
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