Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance.
The study test lens was not the final optical design and the study results were not used for the design validation.
This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.
The study test lens was not the final optical design and the study results were not used for the design validation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenacite contact lens | Experimental | Study Test Contact Lens |
|
| comfilcon A contact lens | Active Comparator | Control Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenacite (Test) contact lens | Device |
| ||
| comfilcon A contact lens |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Visual Acuity (VA) - High Illumination High Contrast | Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter) | Baseline - After 5 minutes of lens settling |
| Binocular Distance Visual Acuity (VA) -High Illumination High Contrast | Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter) | 1 week |
| Binocular Near Visual Acuity (VA) - High Illumination High Contrast | Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter) | Baseline - after 5 minutes of lens dispense |
| Binocular Near Visual Acuity (VA) - High Illumination High Contrast | Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter) | 1-week |
| Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | Baseline (After 5 minutes of lens settling) |
| Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | 1 week |
| Binocular Near Visual Acuity (VA) - Low Illumination High Contrast |
| Measure | Description | Time Frame |
|---|---|---|
| Post Blink Movement - | Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | Baseline (After 5 minutes of lens dispense) |
| Post Blink Movement |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Kollbaum, OD, PhD | Clinical Optics Research Lab (CORL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | 47405 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phenacite Contact Lens Then Comfilcon A | Subjects were randomized to wear test lenses for one week and then cross-over to comfilcon A contact lens for one week. Phenacite : Contact Lens comfilcon A: contact lens |
| FG001 | Comfilcon A Contact Lens Then Phenacite Contact Lens | Subjects were randomized to wear comfilcon A lenses for one week and then cross-over to test contact lens for one week. comfilcon A: contact lens Phenacite : Contact Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear test lens for one week and then cross-over to 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 | Binocular Distance Visual Acuity (VA) - High Illumination High Contrast | Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | logMAR | Baseline - After 5 minutes of lens settling |
|
From dispense up to one week on each study lens, a total of 2 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phenacite Contact Lens | Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain | CooperVision Inc. | 925 730-6754 | PChamberlain@coopervision.com |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) |
| Baseline (after 5 minutes of lens settling) |
| Binocular Near Visual Acuity (VA) - Low Illumination High Contrast | Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | 1week |
| Subjective Ratings for Distance Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | 1 week |
| Subjective Ratings for Intermediate Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | 1 week |
| Subjective Ratings for Near Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | 1 week |
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
| 1 week |
| Push - Up Test for Lens Tightness | Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement | Baseline (After 5 minutes of lens dispense) |
| Push - Up Test for Lens Tightness | Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement | 1 week |
| Lens Mobility Rating | Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps | Baseline (after 5 minutes of lens dispense) |
| Lens Mobility Rating | Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps | 1 week |
| Overall Lens Fit Acceptance | Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps | Baseline (After 5 minutes of lens dispense) |
| Overall Lens Fit Acceptance | Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps | 1 week |
| Subjective Lens Preference - Distance Vision | Patient subjective preference: Phenacite lens, comfilcon A or No Preference | 1 week |
| Subjective Lens Preference -Overall Vision Preference | Patient subjective preference: Phenacite test lens, comfilcon A or No Preference | 1 week |
| Subjective Lens Preference - Comfort | Patient subjective preference: Phenacite test lens, comfilcon A or No Preference | 1 week |
| Subjective Overall Lens Preference | Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference | 1 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 | Binocular Distance Visual Acuity (VA) -High Illumination High Contrast | Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | logMAR | 1 week |
|
|
|
| Primary | Binocular Near Visual Acuity (VA) - High Illumination High Contrast | Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | logMAR | Baseline - after 5 minutes of lens dispense |
|
|
|
| Primary | Binocular Near Visual Acuity (VA) - High Illumination High Contrast | Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | logMAR | 1-week |
|
|
|
| Primary | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | LogMAR | Baseline (After 5 minutes of lens settling) |
|
|
|
| Primary | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | LogMAR | 1 week |
|
|
|
| Primary | Binocular Near Visual Acuity (VA) - Low Illumination High Contrast | Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | LogMAR | Baseline (after 5 minutes of lens settling) |
|
|
|
| Primary | Binocular Near Visual Acuity (VA) - Low Illumination High Contrast | Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | Posted | Mean | Standard Deviation | LogMAR | 1week |
|
|
|
| Primary | Subjective Ratings for Distance Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | score on a scale | 1 week |
|
|
|
| Primary | Subjective Ratings for Intermediate Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | score on a scale | 1 week |
|
|
|
| Primary | Subjective Ratings for Near Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | Posted | Mean | Standard Deviation | score on a scale | 1 week |
|
|
|
| Secondary | Post Blink Movement - | Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | Posted | Mean | Standard Deviation | mm | Baseline (After 5 minutes of lens dispense) |
|
|
|
| Secondary | Post Blink Movement | Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | Posted | Mean | Standard Deviation | mm | 1 week |
|
|
|
| Secondary | Push - Up Test for Lens Tightness | Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 5 minutes of lens dispense) |
|
|
|
| Secondary | Push - Up Test for Lens Tightness | Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Lens Mobility Rating | Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 5 minutes of lens dispense) |
|
|
|
| Secondary | Lens Mobility Rating | Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Overall Lens Fit Acceptance | Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 5 minutes of lens dispense) |
|
|
|
| Secondary | Overall Lens Fit Acceptance | Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Subjective Lens Preference - Distance Vision | Patient subjective preference: Phenacite lens, comfilcon A or No Preference | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Lens Preference -Overall Vision Preference | Patient subjective preference: Phenacite test lens, comfilcon A or No Preference | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Lens Preference - Comfort | Patient subjective preference: Phenacite test lens, comfilcon A or No Preference | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | Subjective Overall Lens Preference | Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference | Posted | Number | percentage of participants | 1 week |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Comfilcon A Contact Lens | Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided