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The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Contact Lens | Active Comparator | Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week. |
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| nelfilcon A lens (control) | Active Comparator | Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Contact Lens | Device | Daily disposable contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | Baseline |
| Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | 1-Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Contact Lens Then Nelfilcon A Lens (Control) | Per randomized schedule, subject will wear a pair of the test lens for one week and then cross-over with the control pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A) |
| FG001 | Nelfilcon A Lens (Control) Then Test Contact Lens | Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Per randomized schedule, subject will wear either a pair of the test lens or control lens for one week and then cross-over to the other pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A) |
| 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 | Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
From dispense up to 1-week on each pair of lenses, a total of two 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 | Test Contact Lens | Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study. Test Contact Lens: Daily disposable contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Hall, BSc, PhD, MCOptom, FBCLA | CooperVision, Inc | 925 251 6684 | lhall@coopervision.com |
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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 | Jul 14, 2017 | Aug 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
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The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.
| Nelfilcon A | Device | Focus Dailies All Day Comfort contact lens (nelfilcon A) |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) | Posted | Mean | Standard Deviation | units on a scale | 1-Week |
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| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Nelfilcon A Lens (Control) | Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study. Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A) | 0 | 45 | 0 | 45 | 0 | 45 |
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