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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.
The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens wear experience | Experimental | Subject will wear contact lenses for about a month during the day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily disposable multifocal soft contact lens | Device | Daily disposable multifocal soft contact lens that will be worn for 1 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (> 50). | 1 month |
| Quality of Life Survey | Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Fogt, OD, MS | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Optometry | Columbus | Ohio | 43210 | United States | ||
| ProCare Vision Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens Wear Experience | Subject will wear contact lenses for about a month during the day. Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lens Wear Experience | Subject will wear contact lenses for about a month during the day. Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (> 50). | Participants | Posted | Count of Participants | Participants | 1 month |
|
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During the entirety of study participation. About 1 month.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | Lens Wear Experience | Subject will wear contact lenses for about a month during the day. Daily disposable multifocal soft contact lens: Daily disposable multifocal soft contact lens that will be worn for 1 month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fogt | The Ohio State University College of Optometry | 614-292-0882 | 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 | Oct 18, 2023 | Nov 19, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Granville |
| Ohio |
| 43023 |
| United States |
| years |
|
| 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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| Primary | Quality of Life Survey | Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey. | Participants | Posted | Count of Participants | Participants | 1 month |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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