Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).
Interventions
DEVICEnelfilcon A contact lens
Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 45 Years
Healthy volunteers
No
Inclusion criteria
* No previous contact lens experience or attempts to try contact lenses (neophytes). * Currently wearing spectacles or needing vision correction in both eyes. * No older than 45 years of age. * Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters. * Interested in wearing contact lenses. * Willing to wear study lenses for at least 8 hours/day, at least 5 days/week. * Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lens Satisfaction | 1 week | Overall Lens Satisfaction, as interpreted by the participant and reported 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 |
Countries
United States
Participant flow
Pre-assignment details
Twenty-seven participants were enrolled but not dispensed. These participants were included in the Actual Enrollment calculation, but not in Participant Flow or Baseline Characteristics calculations.
Participants by arm
| Arm | Count |
|---|---|
| Nelfilcon A Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. | 145 |
| Narafilcon A Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. | 154 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Biomicroscopy | 0 | 1 |
| Overall Study | Discomfort | 1 | 0 |
| Overall Study | Influenza | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Time/job conflict | 2 | 0 |
Baseline characteristics
| Characteristic | Nelfilcon A | Narafilcon A | Total |
|---|---|---|---|
| Age Continuous | 26.5 years STANDARD_DEVIATION 9.8 | 26.5 years STANDARD_DEVIATION 10.5 | 26.5 years STANDARD_DEVIATION 10.12 |
| Sex: Female, Male Female | 94 Participants | 99 Participants | 193 Participants |
| Sex: Female, Male Male | 51 Participants | 55 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 151 | 0 / 163 |
| serious Total, serious adverse events | 0 / 151 | 0 / 163 |
Outcome results
Primary
Overall Lens Satisfaction
Overall Lens Satisfaction, as interpreted by the participant and reported 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: 1 week
Population: Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Overall Lens Satisfaction | 7.9 Units on a Scale | Standard Deviation 1.7 |
| Narafilcon A | Overall Lens Satisfaction | 7.9 Units on a Scale | Standard Deviation 1.6 |