Myopia
Conditions
Brief summary
The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.
Interventions
Silicone hydrogel, spherical, soft contact lens
Sponsors
CIBA VISION
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* On examination, have ocular findings considered to be normal and which would not prevent a subject from safely wearing contact lenses. * Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent. * Be able to wear the study lenses in the available powers. * Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day. * Other protocol inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort After Insertion | 3 months | Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon A Silicone hydrogel, spherical, soft contact lens | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Biomicroscopy | 1 |
| Overall Study | Lack of Efficacy | 12 |
Baseline characteristics
| Characteristic | Lotrafilcon A |
|---|---|
| Age Continuous | 32.4 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Comfort After Insertion
Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 3 months
Population: Per protocol. Analysis excluded major protocol deviations as determined by masked review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A | Comfort After Insertion | 7.9 Scale of 1 to 10 | Standard Deviation 1.6 |