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The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midafilcon A | Active Comparator | Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study. |
|
| somofilcon A | Active Comparator | Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midafilcon A | Device | midafilcon A 1 day daily disposable contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Horizontal Centration | Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal) | Baseline |
| Lens Fit - Horizontal Centration | Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal) | One Week |
| Lens Fit - Vertical Centration | Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior) | Baseline |
| Lens Fit - Vertical Centration | Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior) | One Week |
| Lens Fit - Corneal Coverage | Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | Baseline |
| Lens Fit - Corneal Coverage | Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | One Week |
| Lens Fit - Lens Movement | Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Score for Vision | Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent) | Baseline |
| Subjective Score for Vision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD MCOptom FAAO FBCLA | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CooperVision Inc. | Pleasanton | California | 94588 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Midafilcon A Then Somofilcon A | Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear the cross-over to somofilcon A for one week of daily wear during the study. midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens |
| FG001 | Somofilcon A Then Midafilcon A | Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear then cross-over to midafilcon A for one week of daily wear during the study. somofilcon A: somofilcon A 1 day daily disposable contact lens midafilcon A: midafilcon A 1 day daily disposable contact 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 either midafilcon A 1 day or somofilcon A 1 day for one week of daily wear the cross-over to the other for one week of daily wear during the study. midafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact 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 Fit - Horizontal Centration | Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal) | Posted | Number | percentage of lenses | Baseline |
|
From dispense up to one week for each study 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 | Midafilcon A | Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study. midafilcon A: midafilcon A 1 day daily disposable contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@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 | Sep 25, 2018 | Sep 14, 2020 | Prot_SAP_001.pdf |
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| somofilcon A |
| Device |
somofilcon A 1 day daily disposable contact lens |
|
| Baseline |
| Lens Fit - Lens Movement | Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | One Week |
Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
| One week |
| NOT COMPLETED |
|
| Participants |
|
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Lens Fit - Horizontal Centration | Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal) | Posted | Number | participants of lenses | One Week |
|
|
|
| Primary | Lens Fit - Vertical Centration | Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior) | Posted | Number | percentage of lenses | Baseline |
|
|
|
| Primary | Lens Fit - Vertical Centration | Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior) | Posted | Number | percentage of lenses | One Week |
|
|
|
| Primary | Lens Fit - Corneal Coverage | Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | Posted | Number | percentage of lenses | Baseline |
|
|
|
| Primary | Lens Fit - Corneal Coverage | Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | Posted | Number | percentage of lenses | One Week |
|
|
|
| Primary | Lens Fit - Lens Movement | Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | Posted | Number | percentage of lenses | Baseline |
|
|
|
| Primary | Lens Fit - Lens Movement | Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive) | Posted | Number | percentage of lenses | One Week |
|
|
|
| Secondary | Subjective Score for Vision | Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Subjective Score for Vision | Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent) | Posted | Mean | Standard Deviation | units on a scale | One week |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Somofilcon A | Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study. somofilcon A: somofilcon A 1 day daily disposable contact lens | 0 | 55 | 0 | 55 | 0 | 55 |
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| Optimum |
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| Slightly Temporal |
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| Extremely Temporal |
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| Optimum |
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| Slightly Superior |
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| Extremely Superior |
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| Optimum |
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| Slightly Superior |
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| Extremely Superior |
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
|
| Optimum |
|
| Slightly excessive |
|
| Extremely excessive |
|
| Optimum |
|
| Slightly excessive |
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| Extremely excessive |
|
| Optimum |
|
| Slightly excessive |
|
| Extremely excessive |
|