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The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A toric new lens/etafilcon A toric lens | Active Comparator | The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally. |
|
| etafilcon A toric lens/etafilcon A toric new lens | Active Comparator | The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A toric contact lens with new wetting agent | Device | Investigational toric contact lens made of etafilcon A material with a new wetting agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prescription Equivalence | Number of subjects whose prescription is the same for the two lenses tested. | after 15 minutes of lens wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | United States | ||||
Due to test article shipment error, one clinical site did not receive control test article in a required cylinder and all screened/enrolled subject were unable to be fitted according to the protocol and were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| etafilcon A toric contact lens | Device | Marketed toric contact lens made of etafilcon A material. |
|
| New York |
| New York |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally. |
| 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 | Prescription Equivalence | Number of subjects whose prescription is the same for the two lenses tested. | All completed subjects. | Posted | Number | participants | after 15 minutes of lens 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 | All Subjects | All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally. | 0 | 45 | 0 | 45 |
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Publication requires agreement and written authorization from Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross Franklin, OD | Johnson & Johnson Vision Care | 1-904-443-1379 | RFrankl1@its.jnj.com |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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