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The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A | Active Comparator | contact lens |
|
| lotrafilcon B | Active Comparator | contact lens |
|
| balafilcon A | Active Comparator | contact lens |
|
| methafilcon A | Active Comparator | contact lens |
|
| vifilcon A | Active Comparator | contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | contact lens |
| |
| lotrafilcon B |
| Measure | Description | Time Frame |
|---|---|---|
| Limbal Hyperemia (Redness) | Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 2 weeks |
| Limbal Hyperemia (Redness) | Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 4 weeks |
| Bulbar Hyperemia (Redness) | Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 2 weeks |
| Bulbar Hyperemia (Redness) | Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 4 weeks |
| Corneal Staining | Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 2 weeks |
| Corneal Staining | Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. |
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Inclusion Criteria:
Subjects must:
Exclusion Criteria:
Subject are excluded for the following reasons:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos E Leite Arieta, MD, PhD | Associate Professor - Ophthalmolgy, University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salvador | Estado de Bahia | 41810-570 | Brazil | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A | contact lens senofilcon A: contact lens |
| FG001 | Lotrafilcon B | contact lens lotrafilcon B: contact lens |
| FG002 | Balafilcon A | contact lens balafilcon A: contact lens |
| FG003 | Methafilcon A | contact lens methafilcon A: contact lens |
| FG004 | Vifilcon A | contact lens vifilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This population includes those who were qualified to be in the analysis population. Demographics are not available for those who were excluded or discontinued.
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| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon A | contact lens senofilcon A: contact lens |
| BG001 | Balafilcon A | contact lens balafilcon A: contact lens |
| 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 | Limbal Hyperemia (Redness) | Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | Analysis is on those subjects who were enrolled, randomized, and completed the study. | Posted | Number | eyes | 2 weeks | eyes | eyes |
|
Study period
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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 | Senofilcon A | contact lens senofilcon A: contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Torticollis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos E Leite Arieta MD, PhD | University of Campinas, Brazil | ra-visus-clnclstds@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
| balafilcon A | Device | contact lens |
|
| methafilcon A | Device | contact lens |
|
| vifilcon A | Device | contact lens |
|
| 4 weeks |
| Maringá |
| Paraná |
| 87014-110 |
| Brazil |
| Recife | Pernambuco | 51020-031 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 22640-100 | Brazil |
| Campinas | São Paulo | 13092-320 | Brazil |
| MarÃlia | São Paulo | 17519-030 | Brazil |
| Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| São Paulo | São Paulo | 04063-000 | Brazil |
| São Paulo | São Paulo | 04534-000 | Brazil |
| São Paulo | São Paulo | 05409-001 | Brazil |
| Withdrawal by Subject |
|
| BG002 | Methafilcon A | contact lens methafilcon A: contact lens |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Methafilcon A |
contact lens methafilcon A: contact lens |
|
|
| Primary | Limbal Hyperemia (Redness) | Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study. | Posted | Number | eyes | 4 weeks | eyes | eyes |
|
|
|
| Primary | Bulbar Hyperemia (Redness) | Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | Posted | Number | eyes | 2 weeks | eyes | eyes |
|
|
|
| Primary | Bulbar Hyperemia (Redness) | Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | Analysis is on those who are enrolled, randomized to a study arm, and completed the study. | Posted | Number | eyes | 4 weeks | eyes | eyes |
|
|
|
| Primary | Corneal Staining | Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | Analysis was on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Number | eyes | 2 weeks | eyes | eyes |
|
|
|
| Primary | Corneal Staining | Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Number | eyes | 4 weeks | eyes | eyes |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | Lotrafilcon B | contact lens lotrafilcon B: contact lens | 0 | 3 | 2 | 3 |
| EG002 | Balafilcon A | contact lens balafilcon A: contact lens | 0 | 13 | 0 | 13 |
| EG003 | Methafilcon A | contact lens methafilcon A: contact lens | 0 | 17 | 0 | 17 |
| EG004 | Vifilcon A | contact lens vifilcon A: contact lens | 0 | 3 | 1 | 3 |
| Mild Punctate Keratitis | Eye disorders | Systematic Assessment |
|
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|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Grade 3 |
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| Grade 4 |
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| Title | Measurements |
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| Grade 3 |
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