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The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOA then ULTRA | Other | Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. |
|
| ULTRA then AOA | Other | Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lenses | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear | The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error. | Day 30, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Manager, Vision Care, GCRA | Alcon, A Novartis Division | Study Director |
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Of the 168 enrolled, 1 participant was exited as a screen failure prior to randomization. This reporting group includes all randomized participants (167).
Participants were recruited from 10 investigational sites located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | AOA Then ULTRA | Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. |
| FG001 | ULTRA Then AOA | Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 30 Days of Wear |
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| ||||||||||||||||||
| Period 2, Second 30 Days of Wear |
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This analysis population includes all randomized participants (Intent-to-Treat (ITT) analysis set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. |
| 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 |
| 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 | Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear | The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error. | Intent-to-Treat analysis set | Posted | Mean | Standard Deviation | micrograms | Day 30, each product | Lenses | Lenses |
|
Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (at least 62 days). AEs are reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined.
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 medical device.
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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 | Pretreatment | All subjects who consented to participate in the study prior to the initiation of study treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs Brand Lead, Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000028 | Abortion, Induced |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Samfilcon A contact lenses |
| Device |
|
|
| Hydrogen peroxide solution | Device | Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses |
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| Saline solution | Device | Used for rinsing contact lenses, as needed |
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| NOT COMPLETED |
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| years |
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| Gender | Count of Participants | Participants |
|
Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
|
|
| 0 |
| 168 |
| 0 |
| 168 |
| EG001 | AIR OPTIX AQUA | All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2 | 0 | 166 | 0 | 166 |
| EG002 | ULTRA | All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2 | 0 | 167 | 0 | 167 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.