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This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EALE/1DM | Other | etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
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| 1DM/EALE | Other | etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
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| EADE/1DM | Other | etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
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| 1DM/EADE | Other | etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A control lens (1DM) | Device | A marketed daily disposable contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Monocular Visual Acuity | Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score. | Dispensing |
| Lens Fit Acceptance | The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no). | Dispensing |
| Corneal Staining of Grade 3 or 4 | Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported. | After 7-9 days of lens wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Optometry | Mission Viejo | California | 92691 | United States | ||
| James R Dugue, Optometrist |
Of those 275 enrolled subjects, 267 subjects were randomized and received the study article in the study. Two subjects were discontinued between the first and second periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1DM/EADE | etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for dark eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
| FG001 | 1DM/EALE |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| etafilcon A with print and PVP for light eyes (EALE) | Device | A daily disposable contact lens |
|
| etafilcon A with print and PVP for dark eyes (EADE) | Device | A daily disposable contact lens |
|
| Mission Viejo |
| California |
| 92691 |
| United States |
| Advance Eye Care | Pismo Beach | California | 93448 | United States |
| Golden Vision | Sarasota | Florida | 34242 | United States |
| Eye Associates of Winter Park | Winter Park | Florida | 32789 | United States |
| Eye Care Associates | Bloomington | Illinois | 61701 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Vision Care | East Lansing | Michigan | 48826 | United States |
| Spectrum Eye Care | Jamestown | New York | 14702 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| The Eye Care Group | Grants Pass | Oregon | 97526 | United States |
| Dr. David W Ferris and Associates | Warwick | Rhode Island | 02887 | United States |
| Wishnow Sugar Group | Katy | Texas | 77450 | United States |
| Isthmus Eye Care | Middleton | Wisconsin | 53562 | United States |
| Snowy Range Cision Center | Laramie | Wyoming | 82070 | United States |
etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
| FG002 | EADE/1DM | etafilcon A for dark eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
| FG003 | EALE/1DM | etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. |
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| NOT COMPLETED |
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| Period 2 |
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Baseline summary was conducted on all randomized subjects who worn at least one pair of study lenses.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All randomized subjects who worn at least one pair of study 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 | 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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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Monocular Visual Acuity | Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score. | Analysis was conducted on all randomized subjects who wore at least one pair of study lenses. | Posted | Mean | Standard Deviation | LogMAR score | Dispensing | eyes | eyes |
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| Primary | Lens Fit Acceptance | The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no). | Analysis was conducted on all randomized subjects who wore at least one pair of study lenses. | Posted | Number | 95% Confidence Interval | % of Eyes | Dispensing | eyes | eyes |
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| Primary | Corneal Staining of Grade 3 or 4 | Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported. | Analysis was conducted on all randomized subjects who wore at least one pair of study lenses. | Posted | Number | 95% Confidence Interval | % of Eyes | After 7-9 days of lens wear | eyes | eyes |
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Adverse events were recorded when the subjects were exposed to the Investigational lenses.
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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 | Etafilcon A With PVP for Dark/Light Eyes | A daily disposable contact lens to correct myopia. | 0 | 267 | 0 | 267 | ||
| EG001 | Etafilcon A Control Lenses | A marketed daily disposable contact lens to correct myopia. | 0 | 267 | 0 | 267 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Mayers, O.D., FAAO, Senior Research Optometrist | Vistakon, Johnson and Johnson Vision Care | 1 904 443 3252 | mmayers@its.jnj.com |
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