Myopia
Conditions
Brief summary
The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.
Interventions
Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months
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 participant 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-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort After Insertion | 3 months | Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' 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 Investigational contact lens worn in both eyes for three months | 169 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 9 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Unavailable | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lotrafilcon A |
|---|---|
| Age Continuous | 37.3 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 169 |
| serious Total, serious adverse events | 0 / 169 |
Outcome results
Primary
Comfort After Insertion
Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' 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: Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A | Comfort After Insertion | 9.0 Units on a Scale | Standard Deviation 1.6 |