Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acuvue Advance Plus/ Acuvue Advance | Other | Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second. |
|
| Acuvue Advance/Acuvue Advance Plus | Other | Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acuvue Advance Plus | Device | Silicone hydrogel contact lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity One Week After Lens Wear | Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected. | 1 week |
| Visual Acuity at Time of Initial Fit | Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. | After 10-15 minutes of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Comfort Using Contact Lens User Experience (CLUE) | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winter Park | Florida | United States | ||||
Of the 38 subjects enrolled, 2 were ineligible and not-randomized, 3 discontinued, and 33 completed as cohort.
This is a 3 site, 3 visit, randomized, double-masked, bilateral crossover trial comparing Acuvue Advance to Acuvue Advance Plus lenses.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acuvue Advance Plus/ Acuvue Advance | Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second |
| FG001 | Acuvue Advance/ Acuvue Advance Plus | Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
|
| ||||||||||||||||||
| 1-Week Follow-Up |
| |||||||||||||||||||
| Final Visit |
|
Baseline summary was conducted on subjects who successfully completed the study. There were 38 subjects that started, 3 discontinued, and 2 were ineligible.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Subjects who were randomized and successfully 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, 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 One Week After Lens Wear | Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected. | Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis. | Posted | Least Squares Mean | Standard Error | LogMAR | 1 week | eyes | eyes |
|
1 month, Study took place from Oct 1, 2010-Nov 12, 2010
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acuvue Advance Plus | Acuvue Advance Plus contact lenses |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, O.D., M.S., F.A.A.O. Principal Research Optometrist | Johnson & Johnson Vision Care | 1 904 443-1290 | bpall@its.jnj.com |
Not provided
| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acuvue Advance | Device | Silicone hydrogel contact lens |
|
| 1 week |
| Subject Reported Vision Using Contact Lens User Experience (CLUE). | Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. | 1 week |
| Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) | Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120. | Baseline |
| Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) | Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. | Baseline |
| New York |
| New York |
| United States |
| Nanticoke | Pennsylvania | United States |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Visual Acuity at Time of Initial Fit | Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. | Analysis is conducted on those were enrolled and completed the trial. | Posted | Mean | Standard Deviation | LogMAR | After 10-15 minutes of lens wear | eyes | eyes |
|
|
|
|
| Secondary | Contact Lens Comfort Using Contact Lens User Experience (CLUE) | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. | Analysis was on those who were enrolled and completed the study. | Posted | Least Squares Mean | Standard Error | CLUE points | 1 week |
|
|
|
| Secondary | Subject Reported Vision Using Contact Lens User Experience (CLUE). | Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. | Analysis was on those who were enrolled and completed the study. | Posted | Least Squares Mean | Standard Error | CLUE points | 1 week |
|
|
|
| Secondary | Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) | Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120. | Analysis was on those who were enrolled and completed the study. | Posted | Least Squares Mean | Standard Error | CLUE points | Baseline |
|
|
|
| Secondary | Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) | Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. | Subjects analyzed included only those who were enrolled and completed the study. | Posted | Least Squares Mean | Standard Error | CLUE points | Baseline |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Acuvue Advance | Acuvue Advance contact lenses | 0 | 33 | 0 | 33 |
Not provided
| High Luminance/Low Contrast (Binocular) |
|
| High Luminance/Low Contrast (Monocular) |
|
| For High Luminance/ Low Contrast Grouping (Binocular): Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance). Ha: The test lens (Advance Plus) will be <= to the control lens (Advance). | Mixed Models Analysis | Mean Difference (Final Values) | 0.021 | Standard Error of the Mean | 0.006 | 2-Sided | 95 | 0.0090 | 0.3305 | Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance). | Non-Inferiority or Equivalence | Non-inferiority is assessed with a margin of -0.05 logMAR. |