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The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balafilcon A / etafilcon A | Active Comparator | Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. |
|
| etafilcon A / balafilcon A | Active Comparator | Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balafilcon A contact lens (PureVision) | Device | Commercially marketed, silicone hydrogel contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Front Surface Lens Deposits | Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye 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). | 7 days |
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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 |
Participants meeting eligibility criteria at the screening visit were enrolled into the study. 48 hours of no lens wear prior to Visit 1 served as the washout period. This reporting group includes all enrolled and dispensed participants.
Each site enrolled normal participants (non-depositors) and depositors in approximately a 1:1 ratio, as outlined in the protocol. 54 participants in 3 US sites and 1 UK site were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Balafilcon A / Etafilcon A | Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. |
| FG001 | Etafilcon A / Balafilcon A | Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention, 7 Days (+0/-1) |
| |||||||||||||
| Second Intervention, 7 Days (+0/-1) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all enrolled and dispensed 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 2-5 hours of open eye 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 | 7 days |
|
Adverse events were collected for the duration of the study.
Safety data was collected on all enrolled and dispensed participants.
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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 | Balafilcon A Contact Lenses | Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| etafilcon A contact lens (Acuvue2) | Device | Commercially marketed, hydrogel contact lens |
|
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis. |
| OG001 | Etafilcon A | Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis. |
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Etafilcon A | Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis. | 0 | 54 | 0 | 54 |
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