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This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| narafilcon B | Experimental | contact lens |
|
| etafilcon A | Active Comparator | contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| narafilcon B | Device | contact lens |
| |
| etafilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings - Corneal Edema | Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit. | after 1 week of lens wear |
| Corneal Edema at Month 1 | Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | after 1 month of lens wear |
| Slit Lamp Findings - Corneal Neovascularization | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit. | after 1 week of lens wear |
| Slit Lamp Findings - Corneal Neovascularization | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit. | after 1 month of lens wear |
| Slit Lamp Findings - Corneal Staining | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit. | after 1 week of lens wear |
| Slit Lamp Findings - Corneal Staining |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salt Lake City | Utah | 84106 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Narafilcon B | single use, daily wear contact lens |
| FG001 | Etafilcon A | contact lens worn as single use, daily wear |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Narafilcon B | single use, daily wear contact lens |
| BG001 | Etafilcon A | contact lens worn as single use, daily wear |
| 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 | Slit Lamp Findings - Corneal Edema | Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
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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 | Narafilcon B | single use, daily wear contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch/Principal Research Optometrist | Vistakon | 904-443-1707 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
| after 1 month of lens wear |
| Slit Lamp Findings - Injection | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit. | after 1 week of lens wear |
| Slit Lamp Findings - Injection | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit. | after 1 month of lens wear |
| Slit Lamp Findings - Tarsal Abnormalities | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit. | after 1 week of lens wear |
| Slit Lamp Findings - Tarsal Abnormalities | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit. | after 1 month of lens wear |
| Slit Lamp Findings - Infiltrates | Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit. | after 1 week of lens wear |
| Slit Lamp Findings - Infiltrates | Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit. | after 1 month of lens wear |
| Subject Reported Symptoms | Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear. | after 1 week of lens wear |
| Subject Reported Symptoms | Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear. | after 1 month of lens wear |
| Visual Acuity (VA) | Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit. | after 1 week |
| Visual Acuity (VA) | Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit. | after 1 month |
| Average Wear Time | after 1 week of lens wear |
| Average Wear Time | after 1 month of lens wear |
| Virginia Beach |
| Virginia |
| 23455 |
| United States |
| Laramie | Wyoming | 82070 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| Primary | Corneal Edema at Month 1 | Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Corneal Neovascularization | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Corneal Neovascularization | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Corneal Staining | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Corneal Staining | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Injection | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Injection | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Tarsal Abnormalities | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Tarsal Abnormalities | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Infiltrates | Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
|
|
| Primary | Slit Lamp Findings - Infiltrates | Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month of lens wear | eyes | eyes |
|
|
|
| Primary | Subject Reported Symptoms | Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
|
|
|
| Primary | Subject Reported Symptoms | Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month of lens wear | eyes | eyes |
|
|
|
|
| Primary | Visual Acuity (VA) | Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 week | eyes | eyes |
|
|
|
|
| Primary | Visual Acuity (VA) | Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit. | This analysis includes all participants that completed the study per protocol. | Posted | Number | eyes | after 1 month | eyes | eyes |
|
|
|
|
| Primary | Average Wear Time | This analysis includes all participants that completed the study per protocol. | Posted | Mean | Standard Deviation | hours per day | after 1 week of lens wear |
|
|
|
|
| Primary | Average Wear Time | This analysis includes all participants that completed the study per protocol. | Posted | Mean | Standard Deviation | hours per day | after 1 month of lens wear |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Etafilcon A | contact lens worn as single use, daily wear | 0 | 25 | 0 | 25 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.