Myopia
Conditions
Brief summary
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.
Interventions
Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.
Sponsors
CIBA VISION
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months. * Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner. * Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses. * Other protocol inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Preference | 4 weeks of wear | Overall preference when comparing study lenses to habitual lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer Habitual Lenses; Strongly Prefer Habitual Lenses. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis. | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discomfort | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 33.5 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 152 |
| serious Total, serious adverse events | 0 / 152 |
Outcome results
Primary
Overall Preference
Overall preference when comparing study lenses to habitual lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer Habitual Lenses; Strongly Prefer Habitual Lenses.
Time frame: 4 weeks of wear
Population: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Overall Preference | Strongly Prefer Study Lenses | 28 Participants |
| All Participants | Overall Preference | Somewhat Prefer Study Lenses | 31 Participants |
| All Participants | Overall Preference | NO Preference | 46 Participants |
| All Participants | Overall Preference | Somewhat Prefer Habitual Lenses | 20 Participants |
| All Participants | Overall Preference | Strongly Prefer Habitual Lenses | 20 Participants |