Refractive Error
Conditions
Brief summary
The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.
Interventions
DEVICEHydrogen peroxide solution
Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses
DEVICESaline solution
Used for rinsing contact lenses, as needed
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign informed consent document; * Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses; * Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits; * Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included); * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current); * History of herpetic keratitis, corneal surgery or irregular cornea; * Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator; * Monocular (only 1 eye with functional vision) or fit with only one lens; * Current or past AIR OPTIX® AQUA or ULTRA lens wearers; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear | Day 30, each product | 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. |
Participant flow
Recruitment details
Participants were recruited from 10 investigational sites located in the US.
Pre-assignment details
Of the 168 enrolled, 1 participant was exited as a screen failure prior to randomization. This reporting group includes all randomized participants (167).
Participants by arm
| Arm | Count |
|---|---|
| Overall Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. | 167 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 30 Days of Wear | Adverse Event | 0 | 1 |
| Period 2, Second 30 Days of Wear | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 31.9 years STANDARD_DEVIATION 9.01 |
| Gender Female | 130 Participants |
| Gender Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 168 | 0 / 166 | 0 / 167 |
| serious Total, serious adverse events | 0 / 168 | 0 / 166 | 0 / 167 |
Outcome results
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.
Time frame: Day 30, each product
Population: Intent-to-Treat analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIR OPTIX AQUA (AOA) | Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear | 1.63 micrograms | Standard Deviation 2.21 |
| ULTRA | Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear | 4.89 micrograms | Standard Deviation 3.12 |