Myopia
Conditions
Brief summary
The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.
Interventions
DEVICELotrafilcon A upgrade soft contact lens
Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.
Sponsors
CIBA VISION
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have normal ocular findings. * 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. * Wear Night & Day contact lenses. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Require concurrent ocular medication. * Eye injury or surgery within twelve weeks prior to enrollment. * Currently enrolled in an ophthalmic clinical trial. * Any active corneal infection. * Corneal refractive surgery. * Wear AIR OPTIX NIGHT & DAY AQUA lenses. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 3 months of wear, replacing lenses monthly | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lens Fit | 3 months of wear, replacing lenses monthly | As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight |
Participant flow
Recruitment details
Thirteen US optometry sites recruited and enrolled subjects for this study.
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon A Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights). | 118 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Biomicroscopy | 4 |
| Overall Study | Discomfort | 4 |
| Overall Study | Early exit - Site error | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Time/Job Conflict | 2 |
Baseline characteristics
| Characteristic | Lotrafilcon A |
|---|---|
| Age Continuous | 34.1 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 |
Outcome results
Primary
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 3 months of wear, replacing lenses monthly
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 | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A | Overall Comfort | 8.4 units on a scale | Standard Deviation 1.6 |
Secondary
Overall Lens Fit
As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Time frame: 3 months of wear, replacing lenses monthly
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 | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A | Overall Lens Fit | 0.0 units on a scale | Standard Deviation 0.3 |