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Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenacite | Experimental | Subjects will be randomized to wear the Phenacite contact lenses binocularly. |
|
| comfilcon A | Active Comparator | Subjects will be randomized to wear the comfilcon A contact lenses binocularly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenacite | Device | Subjects will be randomized to wear the Phenacite contact lenses binocularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Lens Comfort | Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt) | Baseline (after 15 minutes of lens dispense) |
| Subjective Ratings of Lens Comfort | Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt) | 2 Weeks |
| Over Refraction for Optimized Distance Acuity | Over Refraction for optimized distance acuity measured using logMAR | 2 weeks |
| Binocular Distance Visual Acuity - High Illumination High Contrast | Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) |
| Binocular Distance Visual Acuity - High Illumination High Contrast | Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR | 2 weeks |
| Binocular Distance Visual Acuity - Low Illumination High Contrast | Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) |
| Binocular Distance Visual Acuity - Low Illumination High Contrast | Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Post Blink Movement | Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | Baseline (after 15 minutes of lens dispense) |
| Lens Fit - Post Blink Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete Kollbaun, OD PhD | CORL Indiana University | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenacite Then Comfilcon A | Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks then cross-over to comfilcon A lenses for two weeks. Phenacite: contact lenses comfilcon A: Contact Lenses |
| FG001 | Comfilcon A Then Phenacite | Subjects will be randomized to wear comfilcon A contact lenses for two weeks then cross-over to Phenacite Lenses for two weeks. comfilcon A: Contact Lenses Phenacite : Contact Lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects will be randomized to wear the Phenacite and comfilcon A contact lenses binocularly for two weeks. Phenacite: contact lenses (Not the final Design - Further clinical studies were conducted to validate the new design) comfilcon A: contact lenses |
| 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 Ratings of Lens Comfort | Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt) | One subject was excluded from the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) |
|
From dispense up to two weeks on each study lenses, a total of four 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 | Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks. Phenacite: contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain | CooperVision Inc. | 925 730-6754 | PChamberlain@coopervision.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| comfilcon A | Device | Subjects will be randomized to wear the comfilcon A contact lenses binocularly. |
|
| 2 weeks |
| Binocular Near Visual Acuity - High Illumination High Contrast | Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) |
| Binocular Near Visual Acuity - High Illumination High Contrast | Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR | 2 weeks |
| Binocular Near Visual Acuity - Low Illumination High Contrast | Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) |
| Binocular Near Visual Acuity - Low Illumination High Contrast | Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR | 2 weeks |
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
| 2 weeks |
| 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 15 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 | 2 weeks |
| 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 15 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 | 2 weeks |
| 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 15 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 | 2 weeks |
| Subjective Ratings for Vision Quality - Distance Vision | Patient subjective scoring using 0-100 continuous scale 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 | Baseline (after 15 minutes of lens dispense) |
| Subjective Ratings for Vision Quality - Distance Vision | Patient subjective scoring using 0-100 continuous scale 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 | 2 weeks |
| Subjective Ratings for Vision Quality - Near Vision | Patient subjective scoring using 0-100 continuous scale 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 | Baseline (after 15 minutes of lens dispense) |
| Subjective Ratings for Vision Quality - Near Vision | Patient subjective scoring using 0-100 continuous scale 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 | 2 weeks |
| Subjective Ratings for Vision Quality - Computer Vision | Patient subjective scoring using 0-100 continuous scale for Computer 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 | Baseline (after 15 minutes of lens dispense) |
| Subjective Ratings for Vision Quality - Computer Vision | Patient subjective scoring using 0-100 continuous scale for Computer 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 | 2 weeks |
| Subjective Ratings for Vision Quality - Overall Vision | Patient subjective scoring using 0-100 continuous scale for Overall 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 | Baseline (after 15 minutes of lens dispense) |
| Subjective Ratings for Vision Quality - Overall Vision | Patient subjective scoring using 0-100 continuous scale for Overall 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 | 2 weeks |
| Corneal Staining Extent | Corneal staining extent was assessed 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 | 2 weeks |
| Conjunctival Staining | Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent | 2 weeks |
| NOT COMPLETED |
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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 Ratings of Lens Comfort | Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt) | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
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| Primary | Over Refraction for Optimized Distance Acuity | Over Refraction for optimized distance acuity measured using logMAR | Posted | Mean | Standard Deviation | logMAR | 2 weeks |
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| Primary | Binocular Distance Visual Acuity - High Illumination High Contrast | Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR | One subject was excluded from the analysis. | Posted | Mean | Standard Deviation | logMAR | Baseline (after 5 minutes of lens dispense) |
|
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| Primary | Binocular Distance Visual Acuity - High Illumination High Contrast | Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR | Posted | Mean | Standard Deviation | logMAR | 2 weeks |
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| Primary | Binocular Distance Visual Acuity - Low Illumination High Contrast | Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR | One subject was excluded from the analysis. | Posted | Mean | Standard Deviation | logMAR | Baseline (after 5 minutes of lens dispense) |
|
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| Primary | Binocular Distance Visual Acuity - Low Illumination High Contrast | Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR | Posted | Mean | Standard Deviation | logMAR | 2 weeks |
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| Primary | Binocular Near Visual Acuity - High Illumination High Contrast | Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR | One subject was excluded from the analysis. | Posted | Mean | Standard Deviation | logMAR | Baseline (after 5 minutes of lens dispense) |
|
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| Primary | Binocular Near Visual Acuity - High Illumination High Contrast | Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR | Posted | Mean | Standard Deviation | logMAR | 2 weeks |
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| Primary | Binocular Near Visual Acuity - Low Illumination High Contrast | Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR | One subject was excluded from the analysis. | Posted | Mean | Standard Deviation | logMAR | Baseline (after 5 minutes of lens dispense) |
|
|
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| Primary | Binocular Near Visual Acuity - Low Illumination High Contrast | Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR | Posted | Mean | Standard Deviation | logMAR | 2 weeks |
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| Secondary | Lens Fit - Post Blink Movement | Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | mm | Baseline (after 15 minutes of lens dispense) |
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| Secondary | Lens Fit - 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 | 2 weeks |
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| 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 | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | mm | Baseline (after 15 minutes of lens dispense) |
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| 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 | mm | 2 weeks |
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| 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 | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) |
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| 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 | 2 weeks |
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| 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 | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) |
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| 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 | 2 weeks |
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| Secondary | Subjective Ratings for Vision Quality - Distance Vision | Patient subjective scoring using 0-100 continuous scale 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 | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) |
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| Secondary | Subjective Ratings for Vision Quality - Distance Vision | Patient subjective scoring using 0-100 continuous scale 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 | units on a scale | 2 weeks |
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| Secondary | Subjective Ratings for Vision Quality - Near Vision | Patient subjective scoring using 0-100 continuous scale 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 | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) |
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| Secondary | Subjective Ratings for Vision Quality - Near Vision | Patient subjective scoring using 0-100 continuous scale 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 | units on a scale | 2 weeks |
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| Secondary | Subjective Ratings for Vision Quality - Computer Vision | Patient subjective scoring using 0-100 continuous scale for Computer 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 | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) |
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| Secondary | Subjective Ratings for Vision Quality - Computer Vision | Patient subjective scoring using 0-100 continuous scale for Computer 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 | units on a scale | 2 weeks |
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| Secondary | Subjective Ratings for Vision Quality - Overall Vision | Patient subjective scoring using 0-100 continuous scale for Overall 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 | One Subject was excluded from the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) |
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| Secondary | Subjective Ratings for Vision Quality - Overall Vision | Patient subjective scoring using 0-100 continuous scale for Overall 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 | units on a scale | 2 weeks |
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| Secondary | Corneal Staining Extent | Corneal staining extent was assessed 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 | 2 weeks |
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| Secondary | Conjunctival Staining | Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Comfilcon A | Subjects will be randomized to wear comfilcon A contact lenses binocularly for two weeks. comfilcon A: contact lenses binocularly. | 0 | 25 | 0 | 25 | 0 | 25 |
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| Temporal |
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| Superior |
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| Inferior |
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| Superior |
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| Inferior |
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