Myopia
Conditions
Brief summary
The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 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
DEVICEEtafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
DEVICEOmafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
DEVICEHilafilcon B contact lens
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 spherical, soft contact lenses replaced at intervals of 2 weeks or monthly. * Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months. * Report 2 or more qualifying symptoms with current contact lenses with a frequency of frequently or all the time * Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense. * Other protocol 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, was reported by the subject 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 all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement. |
Participant flow
Pre-assignment details
Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Participants by arm
| Arm | Count |
|---|---|
| Nelfilcon A Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis | 26 |
| Narafilcon A Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis | 25 |
| Etafilcon A Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis | 26 |
| Omafilcon A Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis | 25 |
| Hilafilcon B Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis | 24 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Failed inclusion criteria | 1 | 1 | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Nelfilcon A | Narafilcon A | Etafilcon A | Omafilcon A | Hilafilcon B | Total |
|---|---|---|---|---|---|---|
| Age Continuous | 29.5 years STANDARD_DEVIATION 7 | 31.5 years STANDARD_DEVIATION 11.9 | 29.9 years STANDARD_DEVIATION 10.1 | 28.3 years STANDARD_DEVIATION 7.7 | 30.5 years STANDARD_DEVIATION 9.6 | 29.9 years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 20 Participants | 19 Participants | 17 Participants | 89 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 6 Participants | 6 Participants | 7 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 24 |
Outcome results
Primary
Lens Awareness
Lens awareness, as interpreted by the subject, was reported by the subject 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 all the time. 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. Analysis excluded major protocol deviations as determined by masked review.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nelfilcon A | Lens Awareness | 16 Participants | 2.3 |
| Narafilcon A | Lens Awareness | 12 Participants | 2.8 |
| Etafilcon A | Lens Awareness | 11 Participants | 3.1 |
| Omafilcon A | Lens Awareness | 9 Participants | 2.5 |
| Hilafilcon B | Lens Awareness | 13 Participants | 3.1 |