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The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PureVision/Acuvue 2 | Other | PureVision contact lenses worn first, with Acuvue 2 contact lenses worn second. Both products worn for 10 hours each. |
|
| Acuvue 2/PureVision | Other | Acuvue 2 contact lenses worn first, with PureVision contact lenses worn second. Both products worn for 10 hours each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balafilcon A contact lenses (PureVision) | Device | Commercially marketed, soft contact lenses worn bilaterally for 10 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Front Surface Lens Deposits | Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both). | 10 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Subjects randomized by lens order to wear PureVision and Acuvue 2 lenses for 10 hours each.
55 Subjects currently wearing hydrogel or silicone hydrogel lenses were recruited at 3 US and 1 United Kingdom study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | PureVision / Acuvue 2 | PureVision lenses worn in Period One, Acuvue 2 lenses worn in Period Two. Both products worn for 10 hours each. |
| FG001 | Acuvue 2 / PureVision | Acuvue 2 lenses worn in Period One, PureVision lenses worn in Period Two. Both products worn for 10 hours each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One, 10 Hours of Wear |
| |||||||||||||
| Period Two, 10 Hours of Wear |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All enrolled participants |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Front Surface Lens Deposits | Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both). | All enrolled participants. | Posted | Number | Participants | 10 hours |
|
Adverse events were collected for the duration of the study.
Safety data was collected on all enrolled and dispensed subjects.
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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 | PureVision Lenses Worn 10 Hours | PureVision lenses worn 10 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Lemp, MS | Alcon Research, Ltd. | 817-615-2739 | Jessie.Lemp@alconlabs.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Etafilcon A contact lenses (Acuvue2) | Device | Commercially marketed, soft contact lenses worn bilaterally for 10 hours |
|
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
PureVision lenses worn 10 hours |
| OG001 | Acuvue 2 Contact Lenses | Acuvue 2 lenses worn 10 hours |
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Acuvue 2 Lenses Worn 10 Hours | Acuvue 2 lenses worn 10 hours | 0 | 55 | 0 | 55 |
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