Astigmatism, Hyperopia, Myopia, Refractive Error
Conditions
Keywords
myopia, hyperopia, astigmatism, contact lenses
Brief summary
The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.
Interventions
DEVICELotrafilcon B toric contact lens
Commercially available, silicone hydrogel contact lens for correction of astigmatism
DEVICEComfilcon A toric contact lens
Commercially available, silicone hydrogel contact lens for correction of astigmatism
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; * Wears toric soft contact lenses; * Can be successfully fit with study lenses within the power ranges available; * Has cylinder of ≥ -0.75 diopter in both eyes; * Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses; * Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any ocular condition that would contraindicate contact lens wear; * Use of medications for which contact lens wear could be contraindicated; * Monocular (only 1 eye with functional vision) or fit with 1 lens; * History of herpetic keratitis, ocular surgery, or irregular cornea; * Known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Requires presbyopic correction; * Use of rewetting/lubricating eye-drops more than twice a day; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ocular Coma Score at 5mm Pupil at Day 30 | Day 30 | Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean. |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in Canada.
Pre-assignment details
Of the 49 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (40).
Participants by arm
| Arm | Count |
|---|---|
| Overall Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 30 Days of Wear | Withdrawal by Subject | 0 | 1 |
| Period 2, Second 30 Days of Wear | Comfort | 0 | 1 |
| Washout Period, 1-13 Days | Inclusion/Exclusion Criteria Not Met | 1 | 0 |
| Washout Period, 1-13 Days | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
Primary
Mean Ocular Coma Score at 5mm Pupil at Day 30
Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.
Time frame: Day 30
Population: This analysis population includes all participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Optix for Astig | Mean Ocular Coma Score at 5mm Pupil at Day 30 | 0.16 micrometers | Standard Deviation 0.09 |
| Biofinity Toric | Mean Ocular Coma Score at 5mm Pupil at Day 30 | 0.24 micrometers | Standard Deviation 0.11 |