A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01416142
Collaborator
(none)
63
1
2
2
30.9
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
63 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens
Study Start Date
:
Jul 1, 2011
Actual Primary Completion Date
:
Aug 1, 2011
Actual Study Completion Date
:
Sep 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Spectacles The subject's habitual spectacles (updated or confirmed as correct within the last 2 years) |
Device: Spectacles
Spectacles to be worn throughout 1/2 of an HD movie.
|
| Experimental: PureVision2 HD contact lenses Currently marketed Bausch + Lomb PureVision2 HD contact lenses |
Device: PureVision2 HD contact lenses
Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [Screening visit (Visit 1) and one week follow-up(Visit 3)]
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.
Secondary Outcome Measures
- Preference for Test Lens [During the movie (Visit 2)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
-
Subjects must be myopic or hyperopic and require lens correction in each eye
-
Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.
Exclusion Criteria:
-
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
-
Any systemic disease affecting ocular health.
-
Using any systemic or topical medications that will affect ocular physiology or lens performance.
-
Allergic to any component in the Biotrue multi-purpose solution
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb, Inc. | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Bev Barna, CCRA, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01416142
Other Study ID Numbers:
- 701E
First Posted:
Aug 12, 2011
Last Update Posted:
Dec 25, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 63 eligible participants were enrolled in the crossover design study, 62 participants completed the study. |
| Arm/Group Title | PureVision2 HD:Spectacles | Spectacles:PureVision2 HD | PureVision2 HD |
|---|---|---|---|
| Arm/Group Description | Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. | Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission. | Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week. |
| Period Title: Cross Over at Movie Intermission | |||
| STARTED | 32 | 31 | 0 |
| COMPLETED | 32 | 31 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
| Period Title: Cross Over at Movie Intermission | |||
| STARTED | 0 | 0 | 63 |
| COMPLETED | 0 | 0 | 62 |
| NOT COMPLETED | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | All Eligible Baseline Participants |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 63 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
19.5
(4.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
33
52.4%
|
| Male |
30
47.6%
|
Outcome Measures
| Title | Visual Acuity |
|---|---|
| Description | 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. |
| Time Frame | Screening visit (Visit 1) and one week follow-up(Visit 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Mean scores are based on the number of eyes with nonmissing logMAR VAs. All eligible, dispensed eyes while wearing spectacles vs. wearing PureVision2 lenses. |
| Arm/Group Title | PureVision2 Lenses | Spectacles |
|---|---|---|
| Arm/Group Description | 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. | The subject's habitual spectacles (updated or confirmed as correct within the last 2 years). |
| Measure Participants | 45 | 45 |
| Measure Eyes | 90 | 90 |
| Mean (Standard Deviation) [logMAR] |
-0.029
(0.074)
|
-0.043
(0.064)
|
| Title | Preference for Test Lens |
|---|---|
| Description | 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. |
| Time Frame | During the movie (Visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All eligible, dispensed subjects |
| Arm/Group Title | PureVision2 Lenses | Spectacles | No Difference |
|---|---|---|---|
| Arm/Group Description | The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. | The subject's habitual spectacles (updated or confirmed as correct within the last 2 years). | Participants reporting no difference between the PureVision2 HD lens and spectacles |
| Measure Participants | 56 | 56 | 56 |
| If a choice, would you prefer glasses or contacts? |
46
73%
|
9
NaN
|
0
NaN
|
| Which were more comfortable to wear? |
24
38.1%
|
20
NaN
|
12
NaN
|
| Which provided you with superior vision? |
39
61.9%
|
6
NaN
|
11
NaN
|
| Which made the experience more enjoyable? |
36
57.1%
|
5
NaN
|
15
NaN
|
Adverse Events
| Time Frame | 1 week | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | PureVision2 Lenses | Spectacles | ||
| Arm/Group Description | The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. | The subject's habitual spectacles (updated or confirmed as correct within the last 2 years). | ||
All Cause Mortality |
||||
| PureVision2 Lenses | Spectacles | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PureVision2 Lenses | Spectacles | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/62 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PureVision2 Lenses | Spectacles | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/62 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Dr. William Reindel |
|---|---|
| Organization | Bausch & Lomb Incorporated |
| Phone | (585) 338-8129 |
| william.reindel@bausch.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01416142
Other Study ID Numbers:
- 701E
First Posted:
Aug 12, 2011
Last Update Posted:
Dec 25, 2013
Last Verified:
Nov 1, 2013