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This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.
This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A then stenfilcon A contact lens | Experimental | Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear. |
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| stenfilcon A then somofilcon A contact lens | Experimental | Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | Contact Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use | Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 4 weeks |
| Subjective Scores of Comfort on Insertion | Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use | Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 4 weeks |
| Subjective Scores on Overall Comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research - The University of Manchester | Manchester | M13 9PL | United Kingdom |
All subjects were fitted with comfilcon A for one month and then the subjects were randomized to wear two daily disposable lenses for one week.
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| ID | Title | Description |
|---|---|---|
| FG000 | Somofilcon A, Then Stenfilcon A Contact Lens | All subjects fitted with the comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear the somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear. comfilcon A : contact lens somofilcon A: daily disposable contact lens stenfilcon A: daily disposable contact lens |
| FG001 | Stenfilcon A, Then Somofilcon A Contact Lens | All subjects fitted with comfilcon A lens on a daily wear, reusable basis for 1 month were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear. comfilcon A: Contact Lens somofilcon A: daily disposable contact lens stenfilcon A: daily disposable contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear comfilcon A lens on a daily wear, reusable basis for 1 month, then fitted and wear the somofilcon A daily disposable test lens and stenfilcon A daily disposable test lens each for 1 week of daily wear. comfilcon A: Contact Lens somofilcon A: daily disposable contact lens stenfilcon A: daily disposable contact lens |
| 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 | Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use | Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | One subject discontinued after dispensing visit. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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From dispense up to 4 weeks for comfilcon A contact lens and from dispense up to one week for somofilcon A and stenfilcon A contact lens, up to 6 weeks total.
Two subjects discontinued from somofilcon A intervention after dispensing. 53 subjects were considered at risk for adverse events for Somofilcon A Contact Lens Arm/Group..
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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 | Comfilcon A Contact Lens | All participants were fitted to wear comfilcon A lens on a daily wear, reusable basis for 1 month. comfilcon A: Contact Lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc., FAAO | CooperVision. Inc | 925 621 3761 | 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 | Jan 28, 2019 | Oct 15, 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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Subjects and investigators will be masked to the study lenses - lenses will be overlabelled.
| somofilcon A | Device | daily disposable contact lens |
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| stenfilcon A | Device | daily disposable contact lens |
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Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
| 1 week |
| Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use | Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 4 weeks |
| Subjective Scores on Comfort Before Removal | Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | 1 week |
| Number of Participants With Horizontal Lens Centration Grade | Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | Baseline (after 5 minutes of lens dispense) |
| Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | 4 weeks |
| Number of Participants With Horizontal Lens Centration Grade | Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | 1 week |
| Number of Participants With Vertical Lens Centration Grade | Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | Baseline (After 5 minutes of lens dispense) |
| Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | 4 weeks |
| Number of Participants With Vertical Lens Centration Grade | Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | 1 week |
| Number of Participants With Lens Corneal Coverage Grade | Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | Baseline (after 5 minutes of lens dispense) |
| Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 4 weeks |
| Number of Participants With Lens Corneal Coverage Grade | Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 1 week |
| Number of Participants With Post-Blink Movement Grade | Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | Baseline (after 5 minutes of lens dispense) |
| Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 4 weeks |
| Number of Participants With Post-Blink Movement Grade | Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | 1 week |
| Investigator Lens Fit Acceptance | Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | Baseline (after 5 minutes of lens dispense) |
| Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use | Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | 4 weeks |
| Investigator Lens Fit Acceptance | Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | 1 week |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| 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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| Primary | Subjective Scores of Comfort on Insertion | Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | 1 week |
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| Secondary | Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use | Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | One Subject discontinued after dispensing visit | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Secondary | Subjective Scores on Overall Comfort | Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | 1 week |
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| Secondary | Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use | Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | One Subject discontinued after dispensing visit | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Secondary | Subjective Scores on Comfort Before Removal | Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | 1 week |
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| Secondary | Number of Participants With Horizontal Lens Centration Grade | Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | Posted | Count of Participants | Participants | Baseline (after 5 minutes of lens dispense) |
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| Secondary | Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | One subject discontinued after dispensing visit | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Number of Participants With Horizontal Lens Centration Grade | Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Number of Participants With Vertical Lens Centration Grade | Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | Posted | Count of Participants | Participants | Baseline (After 5 minutes of lens dispense) |
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| Secondary | Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | One subject discontinued after dispensing visit | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Number of Participants With Vertical Lens Centration Grade | Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Number of Participants With Lens Corneal Coverage Grade | Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | Posted | Count of Participants | Participants | Baseline (after 5 minutes of lens dispense) |
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| Secondary | Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | One subject discontinued after dispensing Visit | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Number of Participants With Lens Corneal Coverage Grade | Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Number of Participants With Post-Blink Movement Grade | Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | Posted | Count of Participants | Participants | Baseline (after 5 minutes of lens dispense) |
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| Secondary | Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | One subject discontinued after dispensing visit | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Number of Participants With Post-Blink Movement Grade | Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Investigator Lens Fit Acceptance | Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | Posted | Number | percentage of lenses | Baseline (after 5 minutes of lens dispense) |
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| Secondary | Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use | Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | One subject discontinued after dispensing visit | Posted | Number | percentage of lenses | 4 weeks |
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| Secondary | Investigator Lens Fit Acceptance | Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) | Posted | Number | percentage of lenses | 1 week |
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| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Somofilcon A Contact Lens | Participants were randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear. somofilcon A: daily disposable contact lens | 0 | 53 | 0 | 53 | 0 | 53 |
| EG002 | Stenfilcon A Contact Lens | Participants were randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear. stenfilcon A: daily disposable contact lens | 0 | 53 | 0 | 53 | 0 | 53 |
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| Title | Measurements |
|---|---|
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| Optimum |
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| Slightly Temporal |
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| Extremely Temporal |
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| Title | Measurements |
|---|---|
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| Slightly Temporal |
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| Extremely Temporal |
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| Optimum |
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| Slightly Temporal |
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| Extremely Temporal |
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| Title | Measurements |
|---|---|
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| Optimum |
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| Slightly Superior |
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| Extremely Superior |
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| Title | Measurements |
|---|---|
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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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| Title | Measurements |
|---|---|
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
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| Title | Measurements |
|---|---|
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| Slightly excessive |
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| Extremely excessive |
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
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| Title | Measurements |
|---|---|
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
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| Title | Measurements |
|---|---|
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| Slightly excessive |
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| Extremely excessive |
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| Optimum |
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| Slightly excessive |
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| Extremely excessive |
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| Title | Measurements |
|---|---|
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