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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.
This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lens, Then Test Lens | Experimental | Participants will wear control lenses for one week and then crossover to test lenses for one week. |
|
| Test Lens, Then Control Lens | Experimental | Participants will wear test lenses for one week and then crossover to control lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Lens (stenfilcon A) | Device | One week wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling on Removal | Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy) | Collected once on day 6 at the end of wear |
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Inclusion Criteria:
Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self-reports having a full eye examination in the previous two years;
Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears soft contact lenses, for the past 3 months minimum;
Has refractive astigmatism no higher than -0.75DC in each eye;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina Wesley | Complete Eye Care of Medina | Principal Investigator |
| Michael Cymbor | Nittany Eye Associates | Principal Investigator |
| Shane Kannarr | Kannarr Eye Care | Principal Investigator |
| Stephen Montaquila | West Bay Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States | ||
| Complete Eye Care of Medina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Lens, Then Test Lens | Participants wore Control Lens for 1 week (Period 1), and then Test Lens for 1 week (Period 2). |
| FG001 | Test Lens, Then Control Lens | Participants wore Test Lens for 1 week (Period 1), and then Control Lens for 1 week (Period 2). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (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 | Feb 23, 2023 |
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| Test Lens (senofilcon A) | Device | One week wear |
|
| Medina |
| Minnesota |
| 55340 |
| United States |
| Nittany Eye Associates | State College | Pennsylvania | 16801 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| Period 2 (1 Week) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Analysis Population | All participants who completed study. (Total study population n=68) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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 | Lens Handling on Removal | Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy) | Total Analysis Population is 68, only those who completed the study. | Posted | Median | Standard Deviation | Units on a scale | Collected once on day 6 at the end of wear |
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|
Duration of the study, approximately 2 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 | Control Lens | Participants that received Control lens during either the first or second period of the study | 0 | 69 | 0 | 69 | 1 | 69 |
| EG001 | Test Lens | Participants that received Test lens during either the first or second period of the study | 0 | 69 | 0 | 69 | 1 | 69 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness and Swelling | Eye disorders | Systematic Assessment |
| ||
| Redness and small bump on lid | Eye disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega | CooperVision | 925-621-3761 | jvega2@coopervision.com |
| Feb 28, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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