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The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ | Other | Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second. |
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| Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ | Other | Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acuvue Advance Plus prePQ | Device | silicone hydrogel contact lens manufactured prior to equipment process qualification activities. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) | Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result. | 6-8 days after lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | 6-8 days after lens wear |
| Limbal Redness |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Powell | Ohio | United States | ||||
44 subjects enrolled; 42 completed as cohort, two subjects were discontinued.
4 investigation sites were used within the U.S. for this study, with a study duration of Oct 23, 2010 to Nov 7, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acuvue Advance Plus preQ/Acuvue Advance Plus postQ | Arm 1: Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second. Arm 2: Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second. |
| FG001 | Acuvue Advance Plus postQ/Acuvue Advance Plus preQ | Arm 1: Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second. Arm 2: Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 1-Week Follow Up |
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| Final Visit |
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44 persons enrolled, 42 completed as cohort, 2 dropped due to: 1 non-trial related adverse event, and 1 protocol deviation
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second. |
| 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 |
| 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 | Visual Acuity (VA) | Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result. | Population analyzed are those who were enrolled, randomized, and completed the study. | Posted | Mean | Standard Deviation | logMAR scale | 6-8 days after lens wear |
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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 | AAP PreQ | Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, O.D., M.S., F.A.A.O. Senior Research Optometrist | Johnson & Johnson Vision Care | (904) 443-1290 | BPALL@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Acuvue Advance Plus postPQ | Device | silicone hydrogel contact lens manufactured after equipment process qualification activities. |
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Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
| 6-8 days after lens wear |
| Bulbar Redness | Scale of 0 increasing to 4. 0=None, 4=Severe Redness | 6-8 days after lens wear |
| Warwick |
| Rhode Island |
| United States |
| Salem | Virginia | United States |
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| 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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| Region of Enrollment | Number | participants |
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| Secondary | Corneal Staining | Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | Population analyzed are those who were enrolled, randomized, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | 6-8 days after lens wear | eyes | eyes |
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| Secondary | Limbal Redness | Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | Population analyzed are those who were enrolled, randomized, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | 6-8 days after lens wear |
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| Secondary | Bulbar Redness | Scale of 0 increasing to 4. 0=None, 4=Severe Redness | Population analyzed consisted of those who were enrolled, randomized, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | 6-8 days after lens wear |
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| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | AAP PostQ | Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification. | 0 | 44 | 0 | 44 |
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