Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectacles | Active Comparator | The subject's habitual spectacles (updated or confirmed as correct within the last 2 years) |
|
| PureVision2 HD contact lenses | Experimental | Currently marketed Bausch + Lomb PureVision2 HD contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PureVision2 HD contact lenses | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | 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. | Screening visit (Visit 1) and one week follow-up(Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Preference for Test Lens | 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. | During the movie (Visit 2) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bev Barna, CCRA | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Inc. | Rochester | New York | 14609 | United States |
63 eligible participants were enrolled in the crossover design study, 62 participants completed the study.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PureVision2 HD:Spectacles | Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. |
| FG001 | Spectacles:PureVision2 HD | Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission. |
| FG002 | PureVision2 HD | Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cross Over at Movie Intermission |
| |||||||||||||
| PureVision2 HD |
|
All Eligible Baseline Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Eligible Baseline 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | 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. | Mean scores are based on the number of eyes with nonmissing logMAR VAs. All eligible, dispensed eyes while wearing spectacles vs. wearing PureVision2 lenses. | Posted | Mean | Standard Deviation | logMAR | Screening visit (Visit 1) and one week follow-up(Visit 3) | Eyes | Participants |
|
1 week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PureVision2 Lenses | The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Reindel | Bausch & Lomb Incorporated | (585) 338-8129 | william.reindel@bausch.com |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Spectacles | Device | Spectacles to be worn throughout 1/2 of an HD movie. |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Spectacles |
The subject's habitual spectacles (updated or confirmed as correct within the last 2 years). |
|
|
| Secondary | Preference for Test Lens | 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. | All eligible, dispensed subjects | Posted | Number | participants | During the movie (Visit 2) |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Spectacles | The subject's habitual spectacles (updated or confirmed as correct within the last 2 years). | 0 | 62 | 0 | 62 |
Not provided
|
| Which provided you with superior vision? |
|
| Which made the experience more enjoyable? |
|