Myopia
Conditions
Brief summary
The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.
Interventions
Investigational, silicone hydrogel, spherical, soft contact lens
Commercially marketed, silicone hydrogel, spherical, soft contact lens
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Currently wearing soft contact lenses * Replaces lenses on a weekly or longer schedule * Other protocol-defined inclusion/
Exclusion criteria
may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort After Insertion | 30-60 seconds after initial insertion | Evaluated by the subject and 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 exposed subjects. | 196 |
| Total | 196 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age Continuous | 30.7 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 196 participants |
| Sex: Female, Male Female | 141 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 196 | 0 / 196 |
| serious Total, serious adverse events | 0 / 196 | 0 / 196 |
Outcome results
Primary
Comfort After Insertion
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 30-60 seconds after initial insertion
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Comfort After Insertion | 8.7 Scale 1-10 | Standard Deviation 1.5 |
| Lotrafilcon A | Comfort After Insertion | 7.7 Scale 1-10 | Standard Deviation 2.4 |