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To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A toric bilaterally | Active Comparator | senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. |
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| balafilcon A toric bilaterally | Active Comparator | balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. |
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| senofilcon A/balafilcon A contralaterally | Active Comparator | senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A toric contact lens | Device | soft contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) |
| Limbal Redness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) |
| Bulbar Redness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) |
| Tarsal Roughness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | 021115 | United States | |||
Total of 112 subjects enrolled, 77 subjects completed study after 3 months. The study was then restricted down to two sites (Australia only) after 3 months with only 37 of the 77 being included. There were 36 subjects whom completed the full 6 month trial period.
Recruitment occurred at 1 site in the USA (n=50 enrolled), and 7 sites in Australia (n=62 enrolled)
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A Bilaterally | Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated. |
| FG001 | Balafilcon A Bilaterally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline to Month 3 (Period 1) |
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| balafilcon A toric contact lens | Device | soft contact lens |
|
| Newtown |
| New South Wales |
| 2042 |
| Australia |
| Camberwell | Victoria | 3124 | Australia |
| Hawthorn | Victoria | 3122 | Australia |
| Keilor | Victoria | 3036 | Australia |
| Melbourne | Victoria | 3000 | Australia |
| Mitcham | Victoria | 3132 | Australia |
| Yallourn | Victoria | 3825 | Australia |
Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated. |
| FG002 | Senofilcon A Toric/Balafilcon A Toric Contralaterally | Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated. |
| COMPLETED |
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| NOT COMPLETED |
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| Month 3 to Month 6 (Period 2) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon A Toric Bilaterally | senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. |
| BG001 | Balafilcon A Toric Bilaterally | balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. |
| BG002 | Senofilcon A/Balafilcon A Contralaterally | senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. |
| BG003 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Staining | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis. | Posted | Mean | Standard Deviation | units on a scale | at 3 months of lens wear (period 1) | eyes | eyes |
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| Primary | Limbal Redness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis. | Posted | Mean | Standard Deviation | units on a scale | at 3 months of lens wear (period 1) | eyes | eyes |
| ||||||||||||||||||||||||||||||
| Primary | Bulbar Redness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis. | Posted | Mean | Standard Deviation | units on a scale | at 3 months of lens wear (period 1) | eyes | eyes |
| ||||||||||||||||||||||||||||||
| Primary | Tarsal Roughness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis. | Posted | Mean | Standard Deviation | units on a scale | at 3 months of lens wear (period 1) | eyes | eyes |
|
6 months
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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 | senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow. | 0 | 87 | 13 | 87 | ||
| EG001 | Balafilcon A | balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow. | 1 | 76 | 9 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microbial Karatitis | Eye disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Significant Events | Eye disorders | Systematic Assessment | These were reported non-specifically as a single category of non-significant events. |
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Publication requires agreement and written consent from the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch, OD | Johnson & Johnson Vision Care, Inc. | 1-904-443-1707 | RA-Visus-ClnclStds@its.jnj.com |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Australia |
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