Refractive Error
Conditions
Keywords
contact lenses, lipids, deposits
Brief summary
The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.
Interventions
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent; * Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1; * Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1; * Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses; * Screening lenses worn 10 hours exhibiting high lipid uptake.
Exclusion criteria
* Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months; * Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months; * 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 for which contact lens wear could be contraindicated, as determined by the Investigator; * Abnormal ocular conditions or findings, as specified in the protocol; * Known pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens | Day 30 after 10 hours of wear, each product | Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis. |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the United Kingdom.
Pre-assignment details
Of the 114 enrolled, 29 subjects were exited prior to randomization. An additional 4 subjects discontinued after randomization but prior to exposure. This reporting group includes all randomized and exposed subjects (81).
Participants by arm
| Arm | Count |
|---|---|
| Overall Lotrafilcon B and senofilcon C contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 30 Days of Wear | Lost to Follow-up | 1 | 1 |
| Period 1, First 30 Days of Wear | Withdrawal by Subject | 2 | 3 |
| Period 2, Second 30 Days of Wear | Adverse Event | 1 | 2 |
| Period 2, Second 30 Days of Wear | Could not attend visit | 1 | 0 |
Baseline characteristics
| Characteristic | Overall | — |
|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 9.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 60 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 78 |
| other Total, other adverse events | 0 / 76 | 0 / 78 |
| serious Total, serious adverse events | 0 / 76 | 0 / 78 |
Outcome results
Primary
Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.
Time frame: Day 30 after 10 hours of wear, each product
Population: Full Analysis Set with non-missing response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AOHG | Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens | 78.1398 micrograms (μg) | Standard Deviation 70.7923 |
| VITA | Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens | 307.6800 micrograms (μg) | Standard Deviation 303.9299 |
p-value: <0.0001Mixed effects repeated measures