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The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.
Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Optix/OFPM | Experimental | Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system |
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| Acuvue Oasys/Habitual MPS | Active Comparator | Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lenses | Device | Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" | Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree. | Day 30; after 4 hours of lens wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie Lemp, PhD | Alcon Research | Study Director |
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Of the 387 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (372).
Subjects were recruited from 22 study sites located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Optix/OFPM | Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system |
| FG001 | Acuvue Oasys/Habitual MPS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Senofilcon A contact lenses | Device | Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions |
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| OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) | Device | Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions |
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| Habitual Multi-Purpose Solution (MPS) | Device | Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions |
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Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
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| NOT COMPLETED |
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This analysis population includes all subjects who were randomized and received study regimen (test or control). Note: 1 subject randomized to Acuvue Oasys was not dispensed with study lenses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Air Optix/OFPM | Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system |
| BG001 | Acuvue Oasys/Habitual MPS | Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" | Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree. | This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Day 30; after 4 hours of lens wear |
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Adverse events (AEs) were collected for duration of study (3 months). This analysis group includes all subjects who were randomized and received study regimen (test or control). Note: 1 subject randomized to Acuvue Oasys was not dispensed study lenses.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. AE data were collected at each study visit.
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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 | Air Optix/OFPM | Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system | 0 | 187 | 0 | 187 | ||
| EG001 | Acuvue Oasys/Habitual MPS | Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system | 0 | 184 | 0 | 184 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Lemp, GMA Brand Lead - Vision Care | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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