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The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants have habitual Comfilcon A Toric lenses optimized for wear over 2 weeks. Then all participants are fit with the Verofilcon A study daily disposable lenses with water surface treatment for astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comfilcon A Toric contact lenses | Device | Monthly replacement contact lenses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism | Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with "Poor Comfort" and 100 anchored as "Excellent Comfort") | 3 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 | Habitual Lens Optimization Followed by Refitting With Study Lenses | All participants are re-fit with habitual Biofinity Toric lenses to optimize vision. Lenses were worn for 2 weeks before returning to be refit with daily disposable lenses with water surface treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Habitual Lens Optimization Followed by Refitting With Study Lenses | All participants are re-fit with habitual Biofinity Toric lenses to optimize vision. Lenses were worn for 2 weeks before returning to be refit with daily disposable lenses with water surface treatment. |
| 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 Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism | Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with "Poor Comfort" and 100 anchored as "Excellent Comfort") | Posted | Median | Inter-Quartile Range | units on a scale | 3 weeks |
|
|
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 | All Participants | All participants are re-fit to optimize fit and vision with their habitual Comfilcon A lenses before being fit with the study lenses. These optimized lenses were worn for 2 weeks before returning to be refit with the study daily disposable lenses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hordeolum/Stye | Eye disorders | Systematic Assessment | A hordeolum (eyelid bump) occurred during the course of the study while wearing the study lens, used warm compresses to treat, then resumed study lens wear and completed the study. Participant reported historical hordeola before participation also. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fogt, OD MS | The Ohio State University College of Optometry | 16142928858 | OPTEyeStudies@osu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2021 | Nov 8, 2023 | Prot_002.pdf |
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| Verofilcon A for Astigmatism Daily Disposable contact lenses |
| Device |
Daily disposable contact lenses |
|
| Participants |
|
| 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 | Number | participants |
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| Participants |
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| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
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