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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contact Lens Wear Experience | Experimental | One week replacement soft contact lenses will be worn for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One week replacement soft contact lenses | Device | One week replacement soft contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Assessment of Lens Wear Experience | VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent) | After 3 weeks of lens wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Optometry | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Contact Lens Wear Experience | One week replacement soft contact lenses will be worn for 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Contact Lens Wear Experience | One week replacement soft contact lenses will be worn for 3 weeks. |
| 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 Assessment of Lens Wear Experience | VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent) | Posted | Count of Participants | Participants | After 3 weeks of lens wear |
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Adverse events were collected for each participant's study duration (~1 month).
The Sub-I or PI conducting each study visit asked participants at the beginning of each visit about any changes to health or medications.
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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 | Contact Lens Wear Experience | One week replacement soft contact lenses will be worn for 3 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fogt | The Ohio State University - Innovation in Eye Care | 6142928858 | fogt.78@osu.edu |
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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 | Nov 25, 2024 | Mar 24, 2026 | Prot_SAP_000.pdf |
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Subjects will be fit into the one week replacement soft contact lens to wear for 3 weeks.
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| 0 |
| 40 |
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| 40 |
| 3 |
| 40 |
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