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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal Optics first, then Single Vision Optics | Other | First Intervention (1 week) Second Intervention (1 week) |
|
| Single Vision Optics first, then Multifocal Optics | Other | First Intervention (1 week) Second Intervention (1 week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact lens with Multifocal Optics | Device | This contact lens has optics to aid the accommodative and convergence systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Eye Fatigue | Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Clinical Optics Research Lab | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multifocal Optics First, Then Single Vision Optics | First intervention (1 week) Second intervention (1 week) |
| FG001 | Single Vision Optics First, Then Multifocal Optics | First Intervention (1 week) Second Intervention (1 week) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
|
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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 8, 2017 |
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| Contact lens with Single Vision Optics | Device | This contact lens has standard single vision optics |
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| COMPLETED |
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| NOT COMPLETED |
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| Second Intervention (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multifocal Optics First, Then Single Vision Optics | First Intervention (1 week) Second Intervention (1 week) |
| BG001 | Single Vision Optics First, Then Multifocal Optics | First Intervention (1 week) Second Intervention (1 week) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | 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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| 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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| 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 | Subject Reported Eye Fatigue | Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above. | Outcome measures reported for both groups combined secondary to crossover design. | Posted | Median | Inter-Quartile Range | units on a scale | 1 week |
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through study completion, an average of 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 | Multifocal Optics First, Then Single Vision Optics | First Intervention (1 week) Second Intervention (1 week) | 0 | 23 | 0 | 23 | 0 | 23 |
| EG001 | Single Vision Optics First, Then Multifocal Optics | First Intervention (1 week) Second Intervention (1 week) | 0 | 22 | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pete Kollbaum | IU School of Optometry | 812-856-0108 | kollbaum@iu.edu |
| Sep 24, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001248 | Asthenopia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| >=65 years |
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| Male |
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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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