Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of daily disposable contact lens wearers.
Interventions
DEVICENelfilcon A contact lens
Spherical, soft contact lens for daily disposable wear
Spherical, soft contact lens for daily disposable wear
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
* Currently wearing any spherical daily disposable contact lens except the two study products for at least 3 months prior to enrollment. * Currently wearing contact lenses at least 8 hours/day and 5 days/week. * Other protocol inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lens Satisfaction | After 1 week of wear | Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall This reporting group includes all enrolled and dispensed subjects. | 178 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, 1 Week of Wear | Randomization break | 0 | 1 |
| Period 2, 1 Week of Wear | Unacceptable lens fit | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 30.0 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 177 | 0 / 178 |
| serious Total, serious adverse events | 0 / 177 | 0 / 178 |
Outcome results
Primary
Overall Lens Satisfaction
Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction 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 |
|---|---|---|---|
| Nelfilcon A Contact Lens | Overall Lens Satisfaction | 7.5 Units on a scale | Standard Deviation 2.2 |
| Narafilcon A Contact Lens | Overall Lens Satisfaction | 7.5 Units on a scale | Standard Deviation 2.3 |