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Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily disposable lens worn first, reusable lens worn second | Experimental | Subject will wear each contact lenses for 30 days during the day only. |
|
| Reusable lens worn first, daily disposable lens worn second | Experimental | Subject will wear each contact lenses for 30 days during the day only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily disposable toric soft contact lens | Device | Daily disposable toric soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Survey of Overall Comfort | Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent" | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States | ||
| The Ohio State University College of Optometry |
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There were 4 screen failures at the first visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily Disposable Lens Worn First, Reusable Lens Worn Second (30 Days) | Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens |
| FG001 |
| 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 | Nov 3, 2022 |
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| Monthly replacement toric daily wear soft contact lens | Device | Monthly replacement toric daily wear soft contact lens |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Reusable Lens Worn First, Daily Disposable Lens Worn Second (30 Days) |
Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Disposable Lens Worn First, Reusable Lens Worn Second | Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens |
| BG001 | Reusable Lens Worn First, Daily Disposable Lens Worn Second | Subject will wear contact lenses for 30 days during the day only. Daily disposable toric soft contact lens: Daily disposable toric soft contact lens Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft 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, Categorical | Drop out subjects were not analyzed. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Drop out subjects not analyzed. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex/Gender, Customized | Drop out subjects not analyzed. | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Drop out subject data not analyzed. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Drop out subjects not analyzed. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Drop out subjects not analyzed. | 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 | Visual Analog Scale Survey of Overall Comfort | Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent" | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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Entire study participation, about 60 days.
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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 Lens | Daily disposable toric soft contact lens: Daily disposable toric soft contact lens | 0 | 63 | 0 | 63 | 0 | 63 |
| EG001 | Reusable Lens | Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens | 0 | 61 | 0 | 61 | 0 | 61 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Fogt, OD, MS | The Ohio State University College of Optometry | 614-292-0882 | fogt.78@osu.edu |
| Apr 1, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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| Transgender Female |
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| Transgender Male |
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| Nonbinary |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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