An interventional study of Lotrafilcon B contact lens (AIR OPTIX® AQUA) and Balafilcon A contact lens (PureVision® 2) in Myopia, sponsored by CIBA VISION. Completed. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by CIBA VISION · Not applicable, Interventional, and Treatment
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.
983 studies on the registry are indexed under Myopia; 209 are open to participants now.
This study's enrollment of 75 is close to the median of 80 across 782 interventional studies indexed under Myopia.
Browse Myopia studies →CIBA VISION is the lead sponsor of 51 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.
Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA) · Device: Contact lens solution (Clear Care®)
Balafilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.
Device: Balafilcon A contact lens (PureVision® 2) · Device: Contact lens solution (Clear Care®)
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.
Also known as: AIR OPTIX® AQUA
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.
Also known as: PureVision® 2
Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.
Also known as: Clear Care®
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
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
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
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
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
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
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
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
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
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
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
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
Participants were recruited from 5 US study centers.
| Milestone | Lotrafilcon B /Balafilcon A |
|---|---|
| Started | 74 |
| Completed | 70 |
| Not completed | 4 |
| Withdrew: Discomfort | 2 |
| Withdrew: Biomicroscopy | 1 |
| Withdrew: Unacceptable fit | 1 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Comfort on Insertion | 8.3 ± 1.6 | 7.5 ± 2.0 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Comfort During the Day | 7.9 ± 1.8 | 7.2 ± 2.0 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Comfort at End of Day | 7.1 ± 2.3 | 6.4 ± 2.3 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Overall Comfort | 7.7 ± 1.9 | 6.9 ± 2.1 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Daytime Vision | 8.7 ± 1.4 | 8.5 ± 1.5 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Low Light Vision | 8.5 ± 1.4 | 8.3 ± 1.6 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Handling on Insertion | 8.5 ± 1.8 | 7.5 ± 2.4 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Handling at Removal | 8.5 ± 1.8 | 7.9 ± 2.2 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Delivers a Healthy, Natural Feeling | 7.9 ± 2.0 | 6.8 ± 2.5 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Lens Awareness | 7.7 ± 2.3 | 6.2 ± 2.8 |
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.
| Units on a Scale | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Overall Satisfaction | 7.8 ± 2.1 | 6.6 ± 2.3 |
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.
| Percent likely to purchase | Lotrafilcon B | Balafilcon A |
|---|---|---|
| Purchase Intent | 64.3 | 35.7 |
Collected over Adverse events were collected for the duration of the trial: 09 FEB 2011 to 07 APR 2011.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lotrafilcon B | — | 0/74 (0%) | 0/74 (0%) |
| Balafilcon A | — | 0/74 (0%) | 0/74 (0%) |
| Age Continuous(years) | Lotrafilcon B /Balafilcon A |
|---|---|
| Mean | 32.8 ± 10.1 |
| Sex: Female, Male(Participants) | Lotrafilcon B /Balafilcon A |
|---|---|
| Female | 54 |
| Male | 20 |
No study locations are listed for this record.
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