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Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).
This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Soft Contact Lens |
|
| Control | Active Comparator | Contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Device | Contact Lens |
| |
| Test |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better | The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes | Evaluated at the 1 week follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mathew | Bausch Health Companies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 117 | Irvine | California | 92618 | United States | ||
| Bausch Site 107 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biotrue | Biotrue ONEday for Astigmatism Soft Contact LensĀ® |
| FG001 | Acuvue | 1-Day Acuvue Moist for Astigmatism Contact Lens |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2018 |
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Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
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Subjects will be dispensed product according to the treatment arm corresponding to their randomization and will be unmasked. The Investigator will be masked.
| Device |
Soft Contact Lens |
|
| San Diego |
| California |
| 92123 |
| United States |
| Bausch Site 101 | San Francisco | California | 94112 | United States |
| Bausch Site 108 | San Jose | California | 95132 | United States |
| Bausch Site 104 | Sunnyvale | California | 94087 | United States |
| Bausch Site 102 | Jacksonville | Florida | 32250 | United States |
| Bausch Site 116 | Bloomington | Illinois | 61701 | United States |
| Bausch Site 110 | Brighton | New York | 14618 | United States |
| Bausch Site 118 | New York | New York | 10022 | United States |
| Bausch Site 111 | New York | New York | 10036 | United States |
| Bausch Site 114 | Raleigh | North Carolina | 27603 | United States |
| Bausch Site 105 | Houston | Texas | 77204 | United States |
| Bausch Site 115 | Issaquah | Washington | 98027 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biotrue | Biotrue ONEday for Astigmatism Soft Contact LensĀ® |
| BG001 | Acuvue | 1-Day Acuvue Moist for Astigmatism Contact Lens |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ancestry | Count of Participants | 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 | Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better | The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes | The Per Protocol (PP) Population included all randomized participants without major protocol deviations who completed the study. | Posted | Count of Participants | Participants | Evaluated at the 1 week follow up visit |
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3 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 | Biotrue | Biotrue ONEday for Astigmatism Soft Contact LensĀ® | 0 | 123 | 0 | 123 | 0 | 123 |
| EG001 | Acuvue | 1-Day Acuvue Moist for Astigmatism Contact Lens | 0 | 119 | 0 | 119 | 0 | 119 |
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Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch & Lomb | 585-338-6399 | Robert.Steffen@bausch.com |
| Nov 23, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-Chinese |
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