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The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A / balafilcon A | Active Comparator | senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second |
|
| balafilcon A/senofilcon A | Active Comparator | balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balafilcon A | Device | multifocal contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity | This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal | after 1 week of wear |
| Near Visual Acuity | This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal. | after 1 week wear |
| Subject Vision | Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. | after 1 week wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. James Weber & Associates | Jacksonville | Florida | 32205 | United States | ||
| Ted Brink & Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/Balafilcon A | senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second |
| FG001 | Balafilcon A/Senofilcon A | balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials. |
| 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 | Distance Visual Acuity | This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal | Analysis includes participants who completed the study per protocol. | Posted | Least Squares Mean | Standard Error | logMAR units | after 1 week of wear |
|
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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 | Senofilcon A/Balafilcon A | senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen OD | Vistakon | 904-443-3402 | tkarkkai@its.jnj.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| senofilcon A | Device | multifocal contact lens |
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Jacksonville | Florida | 32256 | United States |
| Eye Associates of Winter Park | Winter Park | Florida | 32792 | United States |
| Lee Rigel | East Lansing | Michigan | 48823 | United States |
| Timothy R. Poling, OD | Roanoke | Virginia | 24153 | United States |
| Lost to Follow-up |
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| NOT COMPLETED |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Near Visual Acuity | This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal. | Posted | Least Squares Mean | Standard Error | logMAR units | after 1 week wear |
|
|
|
|
| Primary | Subject Vision | Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. | Posted | Least Squares Mean | Standard Error | Scores on a scale | after 1 week wear |
|
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Balafilcon A/Senofilcon A | balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second | 0 | 55 | 0 | 55 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.