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The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A - (Test lens) | Experimental | Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week. |
|
| kalifilcon A - (Control Lens) | Active Comparator | Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A - (Test lens) | Device | Subjects will be randomized to wear test lenses for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Wettability | Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time) | Baseline - after 2 hours of lens wear |
| Lens Wettability | Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time) | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD | Centre for Ocular Research & Education | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States | ||
| Sacco Eye Group, PLLC |
68 participants were screened, 2 subjects discontinued, and 66 subjects were dispensed with the study lenses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A - (Test Lens) Then Kalifilcon A (Control Lens) | Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week. stenfilcon A - (Test lens) kalifilcon A - (Control lens) |
| FG001 | Kalifilcon A - (Control Lens) Then Stenfilcon A - (Test Lens) | Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week. stenfilcon A - (Test lens) kalifilcon A - (Control Lens) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week. stenfilcon A - (Test lens) kalifilcon A - (Control Lens) |
| 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 | Lens Wettability | Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time) | Posted | Mean | Standard Deviation | units on a scale | Baseline - after 2 hours of lens wear |
|
From dispense up to 1 week on each study lens, a total of 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 | Stenfilcon A - (Test Lens) | Subjects were randomized to wear test lenses for one week then cross-over to the control lenses for one week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Abrasion | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc, FAAO | Coopervision | 9256213761 | jvega2@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 | Oct 23, 2020 | Aug 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| kalifilcon A - (Control Lens) | Device | Subjects will be randomized to wear control lenses for one week. |
|
| Vestal |
| New York |
| 13850 |
| United States |
| Athens Eye Care | Athens | Ohio | 45701 | United States |
| Nittany Eye Associates | College | Pennsylvania | 16801 | United States |
| 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 |
|
Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week. kalifilcon A - (Control lens) |
|
|
| Primary | Lens Wettability | Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 1 |
| 66 |
| EG001 | Kalifilcon A - (Control Lens) | Subjects were randomized to wear control lenses for one week then cross-over to the test lenses for one week. | 0 | 66 | 0 | 66 | 0 | 66 |
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