Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.
Interventions
DEVICENelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye. * Able to wear study lenses in the available powers from -1.00D to -6.00D. * Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision Quality | 1 week of wear | Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Pre-assignment details
This reporting group includes all enrolled and dispensed participants.
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled and dispensed participants. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, One Week | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 30.6 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Overall Vision Quality
Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week of wear
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Overall Vision Quality | 8.2 units on a scale | Standard Deviation 1.7 |
| Narafilcon B | Overall Vision Quality | 8.7 units on a scale | Standard Deviation 1.5 |