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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Disposable Toric Contact Lens | Experimental | All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision1® Daily Disposable Toric Contact Lens | Device | Soft, toric contact lens used to correct distance vision and astigmatism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 1 describes poor experience, and 10 describes excellent experience. | Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear. |
| Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 1 describes poor experience, and 10 describes excellent experience. | Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily Disposable Toric Contact Lens | All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Disposable Toric Contact Lens | All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 1 describes poor experience, and 10 describes excellent experience. | Posted | Median | Inter-Quartile Range | units on a scale | Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear. |
|
|
1 month
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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 | Daily Disposable Toric Contact Lens | All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fogt, OD MS | The Ohio State University College of Optometry | 16142928858 | OPTEyeStudies@osu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2020 | Nov 8, 2023 | Prot_002.pdf |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 1 describes poor experience, and 10 describes excellent experience. | Posted | Median | Inter-Quartile Range | units on a scale | Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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