Myopia
Conditions
Brief summary
The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.
Interventions
Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
DEVICEHabitual contact lens
Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly. * Wears lenses at least 5 days per week and at least 12 hours per day. * Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights. * Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of frequently or always. * Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses. * Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses. * Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Upon Insertion | 4 weeks of wear | Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time. |
Participant flow
Pre-assignment details
One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is 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 | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, 4 Weeks of Wear | Failed inclusion/exclusion | 1 | 0 |
| Period 2, 4 Weeks of Wear | Relocation | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age Continuous | 30.4 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 48 |
| serious Total, serious adverse events | 0 / 49 | 0 / 48 |
Outcome results
Primary
Comfort Upon Insertion
Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
Time frame: 4 weeks of wear
Population: Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Comfort Upon Insertion | 8.7 Units on a Scale | Standard Deviation 2 |
| Habitual | Comfort Upon Insertion | 9.2 Units on a Scale | Standard Deviation 0.9 |