Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.
Interventions
DEVICENelfilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
Daily disposable contact lens worn in a daily wear, daily disposable mode
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months. * Habitually wear lenses for at least 8 hours per day and 4 days per week. * Report 2 or more qualifying symptoms with current contact lenses. * Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense. * Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Awareness | 4 weeks of wear | Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nelfilcon A Nelfilcon A contact lens | 32 |
| Narafilcon A Narafilcon A contact lens | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 |
Baseline characteristics
| Characteristic | Nelfilcon A | Narafilcon A | Total |
|---|---|---|---|
| Age Continuous | 31.7 years STANDARD_DEVIATION 8.4 | 35.7 years STANDARD_DEVIATION 11.9 | 33.7 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 17 Participants | 24 Participants | 41 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
Lens Awareness
Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.
Time frame: 4 weeks of wear
Population: Per Protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nelfilcon A | Lens Awareness | 8 Participants |
| Narafilcon A | Lens Awareness | 9 Participants |