Trial Outcomes & Findings for A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens (NCT NCT01416142)
NCT ID: NCT01416142
Last Updated: 2013-12-25
Results Overview
Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.
COMPLETED
NA
63 participants
Screening visit (Visit 1) and one week follow-up(Visit 3)
2013-12-25
Participant Flow
First participant was enrolled on 7/6/2011 and last participant exited the study 8/21/2011. Participants were enrolled from 4 ophthalmology sites in the US. Study visit 1 was the screening visit, visit 2 took place in a movie theatre and visit 3 was 1 week follow-up visit.
63 eligible participants were enrolled in the crossover design study, 62 participants completed the study.
Participant milestones
| Measure |
PureVision2 HD:Spectacles
Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission.
|
Spectacles:PureVision2 HD
Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission.
|
PureVision2 HD
Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week.
|
|---|---|---|---|
|
Cross Over at Movie Intermission
STARTED
|
32
|
31
|
0
|
|
Cross Over at Movie Intermission
COMPLETED
|
32
|
31
|
0
|
|
Cross Over at Movie Intermission
NOT COMPLETED
|
0
|
0
|
0
|
|
PureVision2 HD
STARTED
|
0
|
0
|
63
|
|
PureVision2 HD
COMPLETED
|
0
|
0
|
62
|
|
PureVision2 HD
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
PureVision2 HD:Spectacles
Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission.
|
Spectacles:PureVision2 HD
Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission.
|
PureVision2 HD
Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week.
|
|---|---|---|---|
|
PureVision2 HD
Inability to maintain lens wear
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
Baseline characteristics by cohort
| Measure |
All Eligible Baseline Participants
n=63 Participants
Participants crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
|
|---|---|
|
Age Continuous
|
19.5 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening visit (Visit 1) and one week follow-up(Visit 3)Population: Mean scores are based on the number of eyes with nonmissing logMAR VAs. All eligible, dispensed eyes while wearing spectacles vs. wearing PureVision2 lenses.
Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.
Outcome measures
| Measure |
PureVision2 Lenses
n=90 Eyes
The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. The lower the mean logMAR the better the VA.
|
Spectacles
n=90 Eyes
The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
|
No Difference
Participants reporting no difference between the PureVision2 HD lens and spectacles
|
|---|---|---|---|
|
Visual Acuity
|
-0.029 logMAR
Standard Deviation 0.074
|
-0.043 logMAR
Standard Deviation 0.064
|
—
|
SECONDARY outcome
Timeframe: During the movie (Visit 2)Population: All eligible, dispensed subjects
Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.
Outcome measures
| Measure |
PureVision2 Lenses
n=56 Participants
The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. The lower the mean logMAR the better the VA.
|
Spectacles
n=56 Participants
The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
|
No Difference
n=56 Participants
Participants reporting no difference between the PureVision2 HD lens and spectacles
|
|---|---|---|---|
|
Preference for Test Lens
If a choice, would you prefer glasses or contacts?
|
46 participants
|
9 participants
|
0 participants
|
|
Preference for Test Lens
Which were more comfortable to wear?
|
24 participants
|
20 participants
|
12 participants
|
|
Preference for Test Lens
Which provided you with superior vision?
|
39 participants
|
6 participants
|
11 participants
|
|
Preference for Test Lens
Which made the experience more enjoyable?
|
36 participants
|
5 participants
|
15 participants
|
Adverse Events
PureVision2 Lenses
Spectacles
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER