A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
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|ClinicalTrials.gov Identifier: NCT01416142|
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : December 25, 2013
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: PureVision2 HD contact lenses Device: Spectacles||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||September 2011|
Active Comparator: Spectacles
The subject's habitual spectacles (updated or confirmed as correct within the last 2 years)
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.
- Visual Acuity [ Time Frame: 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.
- Preference for Test Lens [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416142
|United States, New York|
|Bausch & Lomb, Inc.|
|Rochester, New York, United States, 14609|
|Study Director:||Bev Barna, CCRA||Bausch & Lomb Incorporated|