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The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).
This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A | Active Comparator |
| |
| methafilcon A - Interozzo | Active Comparator |
| |
| methafilcon A - CVI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | contact lens |
| |
| methafilcon A - Interozzo |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable. | 1 week per intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep) | Daegu | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A, Methafilcon A-Interozzo, Methafilcon A (CVI) | etafilcon A first, then methafilcon A - Interozzo then methafilcon A (CVI) contact lens |
| FG001 | Etafilcon A, Methafilcon A (CVI), Methafilcon A-Interozzo | etafilcon A first, then methafilcon A (CVI) then methafilcon A - Interozzo contact lens |
| FG002 | Methafilcon A-Interozzo, Methafilcon A (CVI), Etafilcon A | methafilcon A - Interozzo first, then methafilcon A (CVI), then etafilcon A contact lens |
| FG003 | Methafilcon A-Interozzo, Etafilcon A Methafilcon A (CVI) | methafilcon A - Interozzo first, then etafilcon A contact lens, then methafilcon A (CVI) |
| FG004 | Methafilcon A (CVI), Methafilcon A-Interozzo, Etafilcon A | methafilcon A (CVI) first, then methafilcon A - Interozzo, then etafilcon A contact lens |
| FG005 | Methafilcon A (CVI), Etafilcon A, Methafilcon A-Interozzo | methafilcon A (CVI) first, then etafilcon A contact lens, then methafilcon A - Interozzo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 |
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| Week 2 |
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| Week 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants wore enfilcon A, methafilcon A (Interozzo) and methafilcon A (CooperVision) contact lenses. |
| 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 | Comfort | Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable. | Posted | Mean | Standard Deviation | units on a scale | 1 week per intervention |
|
1 week per intervention, 3 weeks total
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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 | All subjects who wore etafilcon A contact lenses as either the first, second or third pair. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, O.D., MSc., FAAO | CooperVision | 9252516213761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2016 | Aug 27, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
| methafilcon A - CVI (CooperVision) | Device | contact lens |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
|
| 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 | Count of Participants | Participants |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Methafilcon A-Interozzo | All subjects who wore methafilcon A-Interozzo contact lenses as either the first, second or third pair. | 0 | 54 | 0 | 54 | 0 | 54 |
| EG002 | Methafilcon A (CVI) | All subjects who wore methafilcon A (CVI) contact lenses as either the first, second or third pair. | 0 | 54 | 0 | 54 | 0 | 54 |
Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.