Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
Not provided
Not provided
Not provided
This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Disposable Contact Lens | Experimental | All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision1® Daily Disposable Contact Lens | Device | Soft, spherical contact lens used to correct distance vision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS) | Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent. | Up to 14 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Daily Disposable Contact Lens | All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daily Disposable Contact Lens | All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision. |
| 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 Overall Comfort as Assessed Using the Visual Analog Scale (VAS) | Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent. | participants | Posted | Median | Inter-Quartile Range | units on a scale | Up to 14 days |
|
|
2 months
Not provided
Not provided
| 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 Contact Lens | All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fogt | The Ohio State University College of Optometry | 16142928858 | OPT-EyeStudies@osu.edu |
Not provided
| 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 14, 2020 | Nov 10, 2022 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
Not provided
Not provided