Myopia
Conditions
Brief summary
The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.
Interventions
DEVICEPureVision2 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.
DEVICESpectacles
Spectacles to be worn throughout 1/2 of an HD movie.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
63 eligible participants were enrolled in the crossover design study, 62 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| PureVision2 HD | Inability to maintain lens wear | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Eligible Baseline Participants |
|---|---|
| Age Continuous | 19.5 years STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PureVision2 Lenses | Visual Acuity | -0.029 logMAR | Standard Deviation 0.074 |
| Spectacles | Visual Acuity | -0.043 logMAR | Standard Deviation 0.064 |
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.
Time frame: During the movie (Visit 2)
Population: All eligible, dispensed subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PureVision2 Lenses | Preference for Test Lens | Which were more comfortable to wear? | 24 participants |
| PureVision2 Lenses | Preference for Test Lens | Which made the experience more enjoyable? | 36 participants |
| PureVision2 Lenses | Preference for Test Lens | Which provided you with superior vision? | 39 participants |
| PureVision2 Lenses | Preference for Test Lens | If a choice, would you prefer glasses or contacts? | 46 participants |
| Spectacles | Preference for Test Lens | Which provided you with superior vision? | 6 participants |
| Spectacles | Preference for Test Lens | If a choice, would you prefer glasses or contacts? | 9 participants |
| Spectacles | Preference for Test Lens | Which made the experience more enjoyable? | 5 participants |
| Spectacles | Preference for Test Lens | Which were more comfortable to wear? | 20 participants |
| No Difference | Preference for Test Lens | Which made the experience more enjoyable? | 15 participants |
| No Difference | Preference for Test Lens | Which were more comfortable to wear? | 12 participants |
| No Difference | Preference for Test Lens | If a choice, would you prefer glasses or contacts? | 0 participants |
| No Difference | Preference for Test Lens | Which provided you with superior vision? | 11 participants |