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| ID | Type | Description | Link |
|---|---|---|---|
| ID08-34 |
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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/nelfilcon A | Active Comparator | etafilcon A contact lens worn first and nelfilcon A contact lens worn second |
|
| nelfilcon A/etafilcon A | Active Comparator | nelfilcon A contact lens worn first and etafilcon A contact lens second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Contact Lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Inferior Region Corneal Staining | The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm) |
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Inclusion Criteria:
Age: 18 years to 45 years
Current daily soft contact lens as habitual optical correction:
Refraction:
Best spectacle corrected visual acuity of 6/9 or better in each eye
Willingness to adhere to the instructions set in the clinical protocol
Signature of the subject on the informed consent form
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otometry Technology Group, Ltd. | London | SW1E 6AU | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/Nelfilcon A | etafilcon A contact lens worn first and nelfilcon A contact lens worn second |
| FG001 | Nelfilcon A/Etafilcon A | nelfilcon A contact lens worn first and etafilcon A contact lens second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Participants | Total number of participants that completed the study. |
| 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 | Overall Comfort | Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | Analysis includes all participants that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | 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 contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, Director Design R&D | Vistakon | 904-443-3088 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| nelfilcon A |
| Device |
Contact Lens |
|
| 1 week |
| End of the Day Comfort | Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 week |
| Initial Comfort | Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 Week |
| Overall Lens Handling | Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | 1 week |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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|
|
| Secondary | Inferior Region Corneal Staining | The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm) | Analysis includes all participants that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 week |
|
|
|
|
| Secondary | End of the Day Comfort | Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | Analysis includes all participants that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 week |
|
|
|
|
| Secondary | Initial Comfort | Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | Analysis includes all participants that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 Week |
|
|
|
|
| Secondary | Overall Lens Handling | Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | Analysis includes all participants that completed the study. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 week |
|
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| EG001 | Nelfilcon A | nelfilcon A contact lenses. | 0 | 122 | 0 | 122 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.