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This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.
This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenacite Test lens then comfilcon A control lens | Experimental | Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week. |
|
| Comfilcon A control lens then Phenacite test Lens | Active Comparator | Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenacite | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) - High Illumination | Distance visual acuity High Illumination was assessed using logMAR | Baseline (after 10 minutes of lens dispense) |
| Distance Visual Acuity (VA) - High Illumination | Distance visual acuity High Illumination was assessed using logMAR | 1 week |
| Near Visual Acuity (VA) - High Illumination | Near Visual Acuity (VA) - High Illumination assessed using logMAR | Baseline (after 10 minutes of lens dispense) |
| Near Visual Acuity (VA) - High Illumination | Near Visual Acuity (VA) - High Illumination assessed using logMAR | 1 week |
| Distance Visual Acuity (VA) - Low Illumination | Distance Visual Acuity (VA) - Low Illumination assessed using logMAR | Baseline (after 10 minutes of lens dispense) |
| Distance Visual Acuity (VA) - Low Illumination | Distance Visual Acuity (VA) - Low Illumination assessed using logMAR | 1 week |
| Near Visual Acuity (VA) - Low Illumination | Near Visual Acuity (VA) - Low illumination assessed using logMAR | Baseline (after 10 minutes of lens dispense) |
| Near Visual Acuity (VA) - Low Illumination |
| Measure | Description | Time Frame |
|---|---|---|
| Biomicroscopy Findings - Bulbar Hyperemia | Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) | 1 week |
| Biomicroscopy Findings- Limbal Hyperemia |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones | CCLR, University of Waterloo | Principal Investigator |
| Pete Kollbaum, OD, PhD | CORL, Indiana University | Principal Investigator |
| Meng Lin, OD, PhD | CRC, University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Berkeley | California | 94720 | United States | ||
| CORL, Indiana University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenacite Test Lens Then Comfilcon A Control Lens | Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week. Phenacite: contact lens comfilcon A: contact lens |
| FG001 | Comfilcon A Control Lens Then Phenacite Test Lens | Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week. Phenacite: contact lens comfilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear phenacite study lens and comfilcon A control lens for one week. |
| 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 | Distance Visual Acuity (VA) - High Illumination | Distance visual acuity High Illumination was assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | Baseline (after 10 minutes of lens dispense) |
|
From dispense up to one week on 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 | Phenacite Test Lens | Participants were randomized to wear Phenacite test lens for one week. Phenacite: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain | CooperVision, Inc. | 925 730-6754 | PChamberlain@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| comfilcon A | Device | contact lens |
|
Near Visual Acuity (VA) - Low illumination assessed using logMAR |
| 1 week |
| Quality of Distance Vision | Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (after 10 minutes of lens dispense) |
| Quality of Distance Vision | Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week |
| Quality of Near Vision | Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time | Baseline (After 10 minutes of lens dispense) |
| Quality of Near Vision | Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time | 1 week |
| Quality of Vision With Digital Device Use | Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (After 10 minutes of lens dispense) |
| Quality of Vision With Digital Device Use | Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week |
| Quality of Intermediate Vision | Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (After 10 minutes of lens dispense) |
| Quality of Intermediate Vision | Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week |
| Overall Vision Quality | Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (After 10 minutes of lens dispense) |
| Overall Vision Quality | Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week |
Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) |
| 1 week |
| Biomicroscopy Findings - Corneal Staining Extent | Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area | 1 week |
| Ghosting - Distance Vision | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable | 1 week |
| Ghosting - Near Vision | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable | 1 week |
| Overall Comfort | Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever. | Baseline (After 10 minutes of lens dispense) |
| Overall Comfort | Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever. | 1 week |
| Overall Dryness | Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time. | Baseline (after 10 minutes of lens dispense) |
| Overall Dryness | Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time. | 1 week |
| Lens Preference - Overall Vision Preference | Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference) | 1 week |
| Subjective Ratings of Change in Frequency of Tiredness | Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week |
| Subjective Ratings of Change in Severity of Tiredness | Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week |
| Subjective Ratings of Change in Bothersome Rating for Tiredness | Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week |
| Subjective Ratings of Change in Frequency of Dryness | Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week |
| Subjective Ratings of Change in Severity of Dryness | Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week |
| Subjective Ratings of Change in Bothersome Rating of Dryness | Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week |
| Subjective Questionnaire Response - Eye Strain | Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree | 1 week |
| Subjective Questionnaire Response - Eye Feel Good | Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree | 1 week |
| Subjective Questionnaire Response - Eye Feel Relaxed | Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree | 1 week |
| Subjective Questionnaire Response - Vision | Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree | 1 week |
| Subjective Questionnaire Response - Eye Tired | Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree | 1 week |
| Bloomington |
| Indiana |
| 47405 |
| United States |
| Center for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
| 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 | Distance Visual Acuity (VA) - High Illumination | Distance visual acuity High Illumination was assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | 1 week |
|
|
|
| Primary | Near Visual Acuity (VA) - High Illumination | Near Visual Acuity (VA) - High Illumination assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | Baseline (after 10 minutes of lens dispense) |
|
|
|
| Primary | Near Visual Acuity (VA) - High Illumination | Near Visual Acuity (VA) - High Illumination assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | 1 week |
|
|
|
| Primary | Distance Visual Acuity (VA) - Low Illumination | Distance Visual Acuity (VA) - Low Illumination assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | Baseline (after 10 minutes of lens dispense) |
|
|
|
| Primary | Distance Visual Acuity (VA) - Low Illumination | Distance Visual Acuity (VA) - Low Illumination assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | 1 week |
|
|
|
| Primary | Near Visual Acuity (VA) - Low Illumination | Near Visual Acuity (VA) - Low illumination assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | Baseline (after 10 minutes of lens dispense) |
|
|
|
| Primary | Near Visual Acuity (VA) - Low Illumination | Near Visual Acuity (VA) - Low illumination assessed using logMAR | Posted | Mean | Standard Deviation | logMAR | 1 week |
|
|
|
| Primary | Quality of Distance Vision | Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 10 minutes of lens dispense) |
|
|
|
| Primary | Quality of Distance Vision | Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Quality of Near Vision | Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 10 minutes of lens dispense) |
|
|
|
| Primary | Quality of Near Vision | Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Quality of Vision With Digital Device Use | Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 10 minutes of lens dispense) |
|
|
|
| Primary | Quality of Vision With Digital Device Use | Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Quality of Intermediate Vision | Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 10 minutes of lens dispense) |
|
|
|
| Primary | Quality of Intermediate Vision | Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Overall Vision Quality | Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 10 minutes of lens dispense) |
|
|
|
| Primary | Overall Vision Quality | Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Biomicroscopy Findings - Bulbar Hyperemia | Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Biomicroscopy Findings- Limbal Hyperemia | Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Biomicroscopy Findings - Corneal Staining Extent | Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Ghosting - Distance Vision | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Ghosting - Near Vision | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Overall Comfort | Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever. | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 10 minutes of lens dispense) |
|
|
|
| Secondary | Overall Comfort | Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Overall Dryness | Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time. | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 10 minutes of lens dispense) |
|
|
|
| Secondary | Overall Dryness | Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Lens Preference - Overall Vision Preference | Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference) | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Subjective Ratings of Change in Frequency of Tiredness | Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Ratings of Change in Severity of Tiredness | Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Ratings of Change in Bothersome Rating for Tiredness | Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Ratings of Change in Frequency of Dryness | Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Ratings of Change in Severity of Dryness | Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Ratings of Change in Bothersome Rating of Dryness | Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Questionnaire Response - Eye Strain | Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Questionnaire Response - Eye Feel Good | Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Questionnaire Response - Eye Feel Relaxed | Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Questionnaire Response - Vision | Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Questionnaire Response - Eye Tired | Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree | Posted | Number | percentage of participants | 1 week |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Comfilcon A Control Lens | Participants were randomized to wear comfilcon A control lens for one week. comfilcon A: contact lens | 0 | 44 | 0 | 44 | 0 | 44 |
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| Temporal |
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| Superior |
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| Inferior |
|
| No Difference |
|
| Worse |
|
| Much Worse |
|
| No Difference |
|
| Worse |
|
| Much Worse |
|
| No Difference |
|
| Worse |
|
| Much Worse |
|
| No Difference |
|
| Worse |
|
| Much Worse |
|
| No Difference |
|
| Worse |
|
| Much Worse |
|
| No Difference |
|
| Worse |
|
| Much Worse |
|