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The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOA Modified | Experimental | Lotrafilcon B sphere modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. |
|
| AOA | Active Comparator | Lotrafilcon B sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B sphere modified design contact lenses | Device |
| ||
| Lotrafilcon B sphere contact lenses |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage. | Dispense (Day 0), Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Manager, Vision Care, GCRA | Alcon Research | Study Director |
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Of the 134 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (132).
Subjects were recruited from 5 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AOA Modified | Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days |
| FG001 | AOA Sphere | Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | AOA Modified | Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days |
| BG001 | AOA Sphere | Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days |
| 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 | Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage. | This analysis population includes all randomized and treated subjects. | Posted | Number | percentage of subjects | Dispense (Day 0), Week 1 |
|
Adverse events (AEs) were collected for the duration of the study (June 2014 - July 2014). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device (test article) and control article.
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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 | Pre-treatment | Includes all subjects / eyes prior to the exposure to the investigational or control products |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Clinical Development, Vision Care, GCRA | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days |
| OG001 | AOA Sphere | Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days |
|
|
| 0 |
| 134 |
| 0 |
| 134 |
| EG001 | AOA Modified | Includes all subjects / eyes exposed to AOA Modified lenses | 0 | 66 | 0 | 66 |
| EG002 | AOA Sphere | Includes all subjects / eyes exposed to AOA Sphere lenses | 0 | 66 | 0 | 66 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.