Myopia, Astigmatism
Conditions
Brief summary
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
Interventions
DEVICEnelfilcon A contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
DEVICEocufilcon D contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters. * Achieve 0.5 or better distance visual acuity in each eye at time of dispense. * Achieve acceptable or optimal fit in each eye at time of dispense. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Habitual daily disposable contact lens wearer. * Sleeps in contact lenses overnight. * Currently enrolled in an ophthalmic clinical trial. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 1 week of wear | Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Pre-assignment details
Three 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 |
|---|---|
| Overall Study This reporting group includes all enrolled and dispensed subjects | 217 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, 1 Week of Wear | Handling | 0 | 1 |
| Period 2, 1 Week of Wear | Unacceptable Vision | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 151 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 217 | 27 / 216 |
| serious Total, serious adverse events | 0 / 217 | 0 / 216 |
Outcome results
Primary
Overall Comfort
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured 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 Comfort | 7.6 Units on a Scale | Standard Deviation 1.9 |
| Ocufilcon D | Overall Comfort | 7.6 Units on a Scale | Standard Deviation 1.9 |