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The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.
This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A | Active Comparator | Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study. |
|
| samfilcon A | Active Comparator | Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | contact lens |
| |
| samfilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses). | Baseline, 2 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comfortable Wearing Time Via SMS (Short Message Service) | Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses). | Days 3, 12, 26 |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Graeme Young | VisionCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Complete Eye Care of Medina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A, Then Samfilcon A | Participants were randomized to wear the comfilcon A lens pair for one month, then cross over to the samfilcon A lens pair. comfilcon A: contact lens samfilcon A: contact lens |
| FG001 | Samfilcon A, Then Comfilcon A | Participants were randomized to wear the samfilcon A lens pair for one month then cross over to the comfilcon A lens pair. samfilcon A: contact lens comfilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Month) |
|
| |||||||||||||||||||||
| Second Intervention (1 Month) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Comfilcon A, Then Samfilcon A | Randomized participants who wore the comfilcon A lens pair for one month, then samfilcon A lens pair during the cross over study. comfilcon A: contact lenses samfilcon A: contact lenses |
| BG001 | Samfilcon A, Then Comfilcon A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Comfort | Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses). | Number of participants analyzed is different from participant flow due to protocol deviations. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks |
|
Adverse event data was collected over the course of the study duration (8 week wear period)
Adverse events were assessed for during the study visits over the duration of the 8 week study.
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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 | Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study. comfilcon A: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager Global Medical Scientific Affairs | CooperVision Inc. | (925) 621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
| Wearing Times |
Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses. |
| Baseline, 2 weeks, 4 weeks |
| Deterioration in Comfort | Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent | Baseline, 2 weeks, 4 weeks |
| Vision Quality | Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied. | Baseline, 2 weeks, 4 weeks |
| Overall Lens Handling | Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle. | Baseline, 2 weeks, 4 weeks |
| Biomicroscopy Scores | Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | Baseline, 2 weeks, 4 weeks |
| Lens Surface Wetting | Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent | Baseline, 2 weeks, 4 weeks |
| Film Deposits | Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye. | 2 weeks and 4 weeks |
| White Spot Deposits | Number of white spot deposits for comfilcon A and samfilcon A lenses. | 2 weeks and 4 weeks |
| Visual Acuity (VA) | Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen. | Baseline, 2 weeks, 4 weeks |
| Lens Centration | Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm) | Baseline, 2 weeks, 4 weeks |
| Corneal Coverage | Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes. Yes = coverage at all times or No = coverage incomplete | Baseline Visit, 2 weeks follow-up, 4-weeks follow-up |
| Post-Blink Movement | Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement | Baseline, 2 weeks, 4 weeks |
| Primary Gaze Lag | Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement | Baseline, 2 weeks, and 4 weeks |
| Lens Tightness Push-up | Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses. Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support | Baseline, 2 weeks, 4 weeks |
| Overall Fit Acceptance | Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect | Baseline, 2 weeks, 4 weeks |
| Dryness | Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry | Baseline, 2 weeks, 4 weeks |
| Medina |
| Minnesota |
| 55340 |
| United States |
| Brock & Houlford | Chew Magna | Bristol | BS40 8PR | United Kingdom |
| Tempany's Boutique Opticians | Broadstone | Dorset | BH18 8DP | United Kingdom |
| David Gould Opticians | Rawtenstall | Lancashire | BB4 7QN | United Kingdom |
| Lens discomfort |
|
| Protocol Violation |
|
| NOT COMPLETED |
|
|
Randomized participants who wore the samfilcon A lens pair for one month, then comfilcon A lens pair during the cross over study. comfilcon A: contact lenses samfilcon A: contact lenses |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Samfilcon A (2 Weeks) | Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study. samfilcon A: contact lens |
| OG003 | Comfilcon A (4 Weeks) | Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study. comfilcon A: contact lens |
| OG004 | Samfilcon A (4 Weeks) | Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study. samfilcon A: contact lens |
|
|
| Secondary | Comfortable Wearing Time Via SMS (Short Message Service) | Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses). | Number of participants analyzed may differ from participant flow due to protocol deviations. | Posted | Mean | Standard Deviation | units on a scale | Days 3, 12, 26 |
|
|
|
| Secondary | Wearing Times | Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses. | Posted | Mean | Standard Deviation | hours | Baseline, 2 weeks, 4 weeks |
|
|
|
| Secondary | Deterioration in Comfort | Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent | Posted | Number | participants | Baseline, 2 weeks, 4 weeks |
|
|
|
| Secondary | Vision Quality | Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied. | Number of participants analyzed differ from participant flow due to protocol deviations. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks |
|
|
|
| Secondary | Overall Lens Handling | Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks |
|
|
|
| Secondary | Biomicroscopy Scores | Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | Lens Surface Wetting | Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | Film Deposits | Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks and 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | White Spot Deposits | Number of white spot deposits for comfilcon A and samfilcon A lenses. | Posted | Mean | Standard Deviation | number of white spots | 2 weeks and 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | Visual Acuity (VA) | Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen. | Posted | Mean | Standard Deviation | LogMAR | Baseline, 2 weeks, 4 weeks |
|
|
|
| Secondary | Lens Centration | Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm) | Posted | Number | Eyes | Baseline, 2 weeks, 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | Corneal Coverage | Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes. Yes = coverage at all times or No = coverage incomplete | Posted | Number | percentage of eyes | Baseline Visit, 2 weeks follow-up, 4-weeks follow-up | Eyes | Eyes |
|
|
|
| Secondary | Post-Blink Movement | Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | Primary Gaze Lag | Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, and 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | Lens Tightness Push-up | Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses. Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support | Posted | Mean | Standard Deviation | percentage of mean lens tightness | Baseline, 2 weeks, 4 weeks | Eyes | Eyes |
|
|
|
| Secondary | Overall Fit Acceptance | Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks |
|
|
|
| Secondary | Dryness | Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks, 4 weeks |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | Samfilcon A | Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study. samfilcon A: contact lens | 0 | 90 | 0 | 90 |
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| 12:00 pm |
|
| 4:00 pm |
|
| 8:00 pm |
|
| Comfortable wearing time |
|
| Maximum wearing time |
|
| No=deterioration in comfort absent |
|
| Ease of removal |
|
| Eyes |
|
| Bulbar Hyperaemia |
|
| Palpebral Conjunctiva |
|
| Corneal Staining |
|
| Conjunctival fluorescein staining |
|
| Eyes |
|
| Eyes |
|
|
| Binocular Distance Visual Acuity |
|
| Eyes |
|
| Decentered slightly |
|
| Substantially decentered |
|
| Eyes |
|
| No |
|
| Eyes |
|
| Eyes |
|
| Eyes |
|
| Prior to removal |
|