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The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilA test/senofilA prod/balafilconA | Active Comparator | Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third. |
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| senofilcon A test/balafilcon A/senofilcon A prod | Active Comparator | Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third. |
|
| senofilcon A prod/senofilcon A test/balafilcon A | Active Comparator | Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third. |
|
| senofilcon A prod/ balifilcon A/ senofilcon A test | Active Comparator | Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third. |
|
| balafilcon A/senofilcon A test/senofilcon A prod |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balafilcon A | Device | multifocal contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity | Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 5 minutes after insertion |
| Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity | Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 5 minutes after insertion |
| Type of Corneal Staining | Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm). | after 1 week of lens wear, for each lens type |
| Overall Subjective Vision | Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | after 1 week of lens wear, for each lens type |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roanoke | Virginia | 24153 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A Test/Senofilcon A Prod/Balafilcon A | Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third. |
| FG001 | Senofilcon A Test/Balafilcon A/Senofilcon A Prod | Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third. |
| FG002 | Senofilcon A Prod/Senofilcon A Test/Balafilcon A | Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, senofilcon A test worn second, and balafilcon A worn third. |
| FG003 | Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test | Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, balafilcon A worn second, and senofilcon A test worn third. |
| FG004 | Balafilcon A/Senofilcon A Test/Senofilcon A Prod | Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third. |
| FG005 | Balafilcon A/Senofilcon A Prod/Senofilcon A Test | Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A producton worn second, senofilcon A test worn third. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall |
| 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 | Overall completed study population |
| 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 Bright Illumination Binocular Visual Performance Reported as Visual Acuity | Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Least Squares Mean | Standard Error | logMAR | 5 minutes after insertion |
|
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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 Test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Karkkainen, OD | Vistakon | 904-443-3402 |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Active Comparator |
Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third. |
|
| balafilcon A/senofilcon A prod/senofilcon A test | Active Comparator | Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third. |
|
| senofilcon A production | Device | multifocal contact lens |
|
| senofilcon A test | Device | multifocal contact lens |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
| OG002 | Balafilcon A | balafilcon A represents subjects that wore this lens in either the first, second, or third period. |
|
|
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| Primary | Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity | Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Least Squares Mean | Standard Error | logMAR | 5 minutes after insertion |
|
|
|
|
| Primary | Type of Corneal Staining | Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm). | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of lens wear, for each lens type |
|
|
|
|
| Primary | Overall Subjective Vision | Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 1 week of lens wear, for each lens type |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Senofilcon A Prod | 0 | 34 | 0 | 34 |
| EG002 | Balafilcon A | 0 | 34 | 0 | 34 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
| Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal. | Mixed Models Analysis | Mean Difference (Final Values) | -0.4608 | Standard Error of the Mean | 0.1464 | 2-Sided | 97.5 | -0.7502 | -0.1714 | The mean difference was calculated as senofilcon A multifocal prod minus balafilcon A multifocal. | Non-Inferiority or Equivalence | Non-inferiority margin = -0.5 |
| Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal. | Mixed Models Analysis | Mean Difference (Final Values) | -0.06765 | Standard Error of the Mean | 0.02656 | 2-Sided | 97.5 | -0.1198 | -0.01553 | The mean difference is calculated as senfilcon A multifocal prod minus balafilcon A multifocal. | Non-Inferiority or Equivalence | Non-inferiority margin = 0.5 |
| Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal. | Mixed Models Analysis | Mean Difference (Final Values) | -0.2281 | Standard Error of the Mean | 0.2243 | 2-Sided | 97.5 | -0.6767 | 0.2206 | The mean difference is calculated as senofilcon A multifocal prod minus balafilcon A multifocal. | Non-Inferiority or Equivalence | Non-inferiority margin = -0.5 |