Astigmatism
Conditions
Brief summary
The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.
Interventions
Silicone hydrogel, toric, soft contact lens
DEVICEComfilcon A contact lens
Silicone hydrogel, toric, soft contact lens
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have a current spectacle prescription, preferably within 6-9 months. * Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear. * Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial. * Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses. * Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | After 1 week of wear | Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study This reporting group includes all enrolled and dispensed subjects. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, One Week | Discomfort | 1 | 0 |
| Period 1, One Week | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age Continuous | 33.4 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Overall Vision
Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: After 1 week of wear
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B Contact Lens | Overall Vision | 8.2 Units on a Scale | Standard Deviation 1.8 |
| Comfilcon A Contact Lens | Overall Vision | 8.3 Units on a Scale | Standard Deviation 1.8 |