Myopia
Conditions
Brief summary
The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.
Interventions
Silicone hydrogel contact lens
DEVICEComfilcon A contact lens
Silicone hydrogel contact lens
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week * Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses * Replace lenses on a weekly or longer schedule * Other protocol inclusion/
Exclusion criteria
may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort at End of Day | After 4 weeks of wear | Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon A Investigational, spherical, silicone hydrogel contact lenses | 107 |
| Comfilcon A Commercially marketed, spherical, silicone hydrogel contact lenses | 106 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | death in the family | 0 | 1 |
| Overall Study | deposits on contact lens | 0 | 1 |
| Overall Study | Lack of Efficacy | 9 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Comfilcon A | Lotrafilcon A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 96 Participants | 192 Participants |
| Age, Continuous | 31.8 years STANDARD_DEVIATION 11 | 30.6 years STANDARD_DEVIATION 9.8 | 31.2 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 106 participants | 107 participants | 213 participants |
| Sex: Female, Male Female | 84 Participants | 84 Participants | 168 Participants |
| Sex: Female, Male Male | 22 Participants | 23 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 107 | 0 / 106 |
| serious Total, serious adverse events | 0 / 107 | 0 / 106 |
Outcome results
Primary
Comfort at End of Day
Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: After 4 weeks of wear
Population: One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A | Comfort at End of Day | 6.5 Scale of 1-10 | Standard Deviation 2.4 |
| Comfilcon A | Comfort at End of Day | 6.9 Scale of 1-10 | Standard Deviation 2.4 |