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| Name | Class |
|---|---|
| Eurolens Research | INDUSTRY |
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The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A/etafilcon A | Active Comparator | Period 1: etafilcon A, Period 2: etafilcon A |
|
| etafilcon A/omafilcon A | Active Comparator | Period 1: etafilcon A, Period 2: omafilcon A |
|
| omafilcon A/etafilcon A | Active Comparator | Period 1: omafilcon A, Period 2: etafilcon A |
|
| omafilcon A/omafilcon A | Active Comparator | Period 1: omafilcon A, Period 2: omafilcon A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Comfort | A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M60 1QD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A / Etafilcon A | Period 1: etafilcon A, Period 2: etafilcon A |
| FG001 | Etafilcon A / Omafilcon A | Period 1: etafilcon A, Period 2: omafilcon A |
| FG002 | Omafilcon A / Etafilcon A | Period 1: omafilcon A, Period 2: etafilcon A |
| FG003 | Omafilcon A / Omafilcon A | Period 1: omafilcon A, Period 2: omafilcon A |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One |
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| ||||||||||||||||||
| Period Two |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Population |
| 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 | Distance Visual Acuity | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Least Squares Mean | Standard Error | logMar | 1 week |
|
|
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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 / Etafilcon A | Period 1: etafilcon A, Period 2: etafilcon A |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD, FAAO | Vistakon | 904-443-3088 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| omafilcon A | Device | contact lens |
|
| ineligible |
|
| Adverse Event |
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| Withdrawal by Subject |
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| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Lens Comfort | A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable | Posted | Least Squares Mean | Standard Error | Units on a scale | 1 week |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Etafilcon A / Omafilcon A | Period 1: etafilcon A, Period 2: omafilcon A | 0 | 10 | 0 | 10 |
| EG002 | Omafilcon A / Etafilcon A | Period 1: omafilcon A, Period 2: etafilcon A | 0 | 17 | 0 | 17 |
| EG003 | Omafilcon A / Omafilcon A | Period 1: omafilcon A, Period 2: omafilcon A | 0 | 17 | 0 | 17 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.