Refractive Error
Conditions
Brief summary
The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
Detailed description
Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.
Interventions
DEVICELotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Lotrafilcon B contact lenses packaged with copolymer 845
DEVICEHydrogen peroxide-based lens care solution
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
DEVICESaline solution for rinsing contact lenses
Commercially-available saline solution used as needed
DEVICESaline solution for rinsing contact lens case
Commercially-available solution used as needed
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign Informed Consent Document; * Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye; * Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range; * Willing to answer text messages on a daily basis during the study; * Willing to discontinue artificial tears and rewetting drops on the days of study visits; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week); * 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; * Monocular (only 1 eye with functional vision) or fit with only 1 lens; * Pregnant or lactating; * Participation in any clinical study within 30 days of Visit 1; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Satisfying the no Re-fit Criteria in Both Eyes | Day 30, each product | Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear | Day 30, each product | The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis. |
| Change From Insertion in Minimum Protected Area (MPA) | Hour 0 (Lens Insertion) to Hour 12 on Day 1 | MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the United Kingdom (UK).
Pre-assignment details
Of the 82 enrolled, 6 subjects were exited as screen failures prior to randomization. One subject withdrew consent after randomization, but before exposure to product. This reporting group includes all randomized and exposed subjects (75).
Participants by arm
| Arm | Count |
|---|---|
| Overall Lotrafilcon B contact lenses with EOBO-41 and lotrafilcon B contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment, as randomized. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, Second 30 Days of Wear | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 0 / 82 | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 82 | 1 / 75 | 0 / 75 |
Outcome results
Primary
Percentage of Subjects Satisfying the no Re-fit Criteria in Both Eyes
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
Time frame: Day 30, each product
Population: Full Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AOHG Contact Lenses | Percentage of Subjects Satisfying the no Re-fit Criteria in Both Eyes | 93.3 percentage of subjects |
| AOA Contact Lenses | Percentage of Subjects Satisfying the no Re-fit Criteria in Both Eyes | 94.6 percentage of subjects |
Secondary
Change From Insertion in Minimum Protected Area (MPA)
MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.
Time frame: Hour 0 (Lens Insertion) to Hour 12 on Day 1
Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AOHG Contact Lenses | Change From Insertion in Minimum Protected Area (MPA) | Insertion (Hour 0) | 86.839 percentage of contact lens surface area | Standard Deviation 24.775 |
| AOHG Contact Lenses | Change From Insertion in Minimum Protected Area (MPA) | Change from Insertion (Hour 12 - Hour 0) | 4.396 percentage of contact lens surface area | Standard Deviation 23.06 |
Secondary
Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.
Time frame: Day 30, each product
Population: Full Analysis Set. Only the right (OD) lenses were collected from a subset of subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AOHG Contact Lenses | Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear | 0.44 μg | Standard Deviation 0.231 |
| AOA Contact Lenses | Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear | 0.27 μg | Standard Deviation 0.173 |