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The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.
The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test lens | Experimental | Subjects wearing the test lens for one week, either randomized as the first or second pair. |
|
| Control lens | Active Comparator | Subjects wearing the control lens for one week, either randomized as the first or second pair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test lens | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lens Centration | Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I) | Baseline |
| Number of Participants With Lens Centration | Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I) | 1 week |
| Post Blink Movement | Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink) | Baseline |
| Post Blink Movement | Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink) | 1 week |
| Primary Gaze Lag | Primary Gaze Lag (measured in mm at 0.1mm steps) | baseline |
| Primary Gaze Lag | Primary Gaze Lag (measured in mm at 0.1mm steps) | 1 week |
| Up Gaze Lag | Up Gaze Lag (measured in mm at 0.1mm steps) | Baseline |
| Up Gaze Lag |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort Rating | Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable) | Baseline |
| Subjective Comfort Rating | Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Eye Center at Ketchum Health | Anaheim | California | 92807 | United States | ||
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens Then Control Lens | Subjects were randomized to wear the test lens for one week then the control lens for one week. Test lens: contact lens |
| FG001 | Control Lens Then Test Lens | Subjects were randomized to wear the control lens for one week then the test lens for one week. Control lens: 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 | Total Participants |
| 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 | Number of Participants With Lens Centration | Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I) | Posted | Count of Participants | Participants | Baseline |
|
From baseline up to 1 week for each intervention, 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 | Test Lens | Subjects were randomized to wear the test lens for one week. Test lens: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision, Inc. | 925-730-6716 | mnguyen@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 | Dec 17, 2018 | May 13, 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, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
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Double (participant and investigator)
| Control lens | Device | contact lens |
|
|
Up Gaze Lag (measured in mm at 0.1mm steps)
| 1 week |
| Push-Up Tightness | Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement) | baseline |
| Push-Up Tightness | Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement) | 1 week |
| Overall Fit Acceptance | Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum | Baseline |
| Overall Fit Acceptance | Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum | 1 week |
| Number of Participants With Overall Lens Fit Impression | Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable | Baseline |
| Number of Participants With Overall Lens Fit Impression | Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable | 1 week |
| 1-week |
| Bloomington |
| Indiana |
| 47405 |
| United States |
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| Participants |
|
| 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 | Number of Participants With Lens Centration | Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I) | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Primary | Post Blink Movement | Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink) | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline |
|
|
|
| Primary | Post Blink Movement | Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink) | Posted | Mean | Standard Deviation | millimeters (mm) | 1 week |
|
|
|
| Primary | Primary Gaze Lag | Primary Gaze Lag (measured in mm at 0.1mm steps) | Posted | Mean | Standard Deviation | millimeters (mm) | baseline |
|
|
|
| Primary | Primary Gaze Lag | Primary Gaze Lag (measured in mm at 0.1mm steps) | Posted | Mean | Standard Deviation | millimeters (mm) | 1 week |
|
|
|
| Primary | Up Gaze Lag | Up Gaze Lag (measured in mm at 0.1mm steps) | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline |
|
|
|
| Primary | Up Gaze Lag | Up Gaze Lag (measured in mm at 0.1mm steps) | Posted | Mean | Standard Deviation | millimeters (mm) | 1 week |
|
|
|
| Primary | Push-Up Tightness | Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement) | Posted | Mean | Standard Deviation | percentage | baseline |
|
|
|
| Primary | Push-Up Tightness | Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement) | Posted | Mean | Standard Deviation | percentage | 1 week |
|
|
|
| Primary | Overall Fit Acceptance | Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Overall Fit Acceptance | Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Number of Participants With Overall Lens Fit Impression | Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Number of Participants With Overall Lens Fit Impression | Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Subjective Comfort Rating | Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Subjective Comfort Rating | Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable) | Posted | Mean | Standard Deviation | units on a scale | 1-week |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Control Lens | Subjects were randomized to wear the test lens for one week. Control lens: contact lens | 0 | 52 | 0 | 52 | 0 | 52 |
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| Extreme Decentered |
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| Optimal |
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| Excessive Acceptable |
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| Excessive Unacceptable |
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| Optimal |
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| Excessive Acceptable |
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| Excessive Unacceptable |
|