Myopia
Conditions
Brief summary
The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.
Interventions
Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
DEVICEBalafilcon A contact lens (PureVision® 2)
Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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 brand with a recommended replacement schedule of 2 weeks or greater. * Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses. * Willing and able to wear spherical contact lenses within the available range of powers. * Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Eye injury or surgery within twelve weeks prior to enrollment. * Currently enrolled in any clinical trial. * Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. * Astigmatism of 1.00D or more. * Currently wearing contact lenses in a daily disposable modality. * Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses * Currently sleeping overnight in contact lenses on an occasional or extended wear basis. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort on Insertion | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Comfort During the Day | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Comfort at End of Day | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Overall Comfort | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Daytime Vision | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Low Light Vision | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Handling on Insertion | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy. |
| Handling at Removal | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy. |
| Delivers a Healthy, Natural Feeling | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Lens Awareness | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware. |
| Overall Satisfaction | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent. |
| Purchase Intent | 4 weeks | As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses. |
Participant flow
Recruitment details
Participants were recruited from 5 US study centers.
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 in the Participant Flow or Baseline Characteristics calculations.
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon B /Balafilcon A Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Biomicroscopy | 1 |
| Overall Study | Discomfort | 2 |
| Overall Study | Unacceptable fit | 1 |
Baseline characteristics
| Characteristic | Lotrafilcon B /Balafilcon A |
|---|---|
| Age Continuous | 32.8 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 |
Outcome results
Primary
Comfort at End of Day
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Comfort at End of Day | 7.1 Units on a Scale | Standard Deviation 2.3 |
| Balafilcon A | Comfort at End of Day | 6.4 Units on a Scale | Standard Deviation 2.3 |
Primary
Comfort During the Day
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Comfort During the Day | 7.9 Units on a Scale | Standard Deviation 1.8 |
| Balafilcon A | Comfort During the Day | 7.2 Units on a Scale | Standard Deviation 2 |
Primary
Comfort on Insertion
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
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 B | Comfort on Insertion | 8.3 Units on a Scale | Standard Deviation 1.6 |
| Balafilcon A | Comfort on Insertion | 7.5 Units on a Scale | Standard Deviation 2 |
Primary
Daytime Vision
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Daytime Vision | 8.7 Units on a Scale | Standard Deviation 1.4 |
| Balafilcon A | Daytime Vision | 8.5 Units on a Scale | Standard Deviation 1.5 |
Primary
Delivers a Healthy, Natural Feeling
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Delivers a Healthy, Natural Feeling | 7.9 Units on a Scale | Standard Deviation 2 |
| Balafilcon A | Delivers a Healthy, Natural Feeling | 6.8 Units on a Scale | Standard Deviation 2.5 |
Primary
Handling at Removal
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Handling at Removal | 8.5 Units on a Scale | Standard Deviation 1.8 |
| Balafilcon A | Handling at Removal | 7.9 Units on a Scale | Standard Deviation 2.2 |
Primary
Handling on Insertion
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Handling on Insertion | 8.5 Units on a Scale | Standard Deviation 1.8 |
| Balafilcon A | Handling on Insertion | 7.5 Units on a Scale | Standard Deviation 2.4 |
Primary
Lens Awareness
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Lens Awareness | 7.7 Units on a Scale | Standard Deviation 2.3 |
| Balafilcon A | Lens Awareness | 6.2 Units on a Scale | Standard Deviation 2.8 |
Primary
Low Light Vision
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Low Light Vision | 8.5 Units on a Scale | Standard Deviation 1.4 |
| Balafilcon A | Low Light Vision | 8.3 Units on a Scale | Standard Deviation 1.6 |
Primary
Overall Comfort
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Overall Comfort | 7.7 Units on a Scale | Standard Deviation 1.9 |
| Balafilcon A | Overall Comfort | 6.9 Units on a Scale | Standard Deviation 2.1 |
Primary
Overall Satisfaction
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon B | Overall Satisfaction | 7.8 Units on a Scale | Standard Deviation 2.1 |
| Balafilcon A | Overall Satisfaction | 6.6 Units on a Scale | Standard Deviation 2.3 |
Primary
Purchase Intent
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon B | Purchase Intent | 64.3 Percent likely to purchase |
| Balafilcon A | Purchase Intent | 35.7 Percent likely to purchase |