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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.
This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants | Experimental | All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for ~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Disposable Contact Lens | Device | Soft, daily disposable spherical contact lens used to correct distance vision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey | Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Fogt, OD, MS | The Ohio State University College of Optometry | Principal Investigator |
| 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 | Single Arm Study | All subjects are re-fit into their habitual reusable soft contact lenses to optimize vision. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Subjects then return and are fit with the daily disposable soft contact lens. After wearing the daily disposable lenses, participants return to assess vision and lens fit and answer surveys about their experience. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Wear Study Daily Disposable Contact Lenses | All subjects are re-fit into their habitual reusable soft contact lenses to optimize vision. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Subjects then return and are fit with the daily disposable soft contact lens. After wearing the daily disposable lenses, participants return to assess vision and lens fit and answer surveys about their experience. |
| 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 |
| 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 | Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey | Participants complete the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey. This is an 8 question survey assesses symptoms while wearing contact lenses with possible scores from 0 (no symptoms) to 37 (maximum symptoms). Higher scores indicate worsening symptoms of dry eye while wearing lenses. | All subjects were in the same arm, and wore both types of lenses. This was not a comparative study. | Posted | Median | Inter-Quartile Range | units on a scale | 2 weeks |
|
4 weeks
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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 | All Study Participants | All subjects are re-fit into their habitual reusable soft contact lenses to optimize vision. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Subjects then return and are fit with the daily disposable soft contact lens. After wearing the daily disposable lenses, participants return to assess vision and lens fit and answer surveys about their experience. Adverse events were not collected separately for the habitual reusable lenses and daily disposable lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fogt | The Ohio State University College of Optometry | 16142928858 | OPT-EyeStudies@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 | Jun 25, 2020 | Oct 13, 2022 | Prot_SAP_000.pdf |
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This is a single arm, non-comparative study.
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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 | Count of Participants | Participants |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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