Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
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|ClinicalTrials.gov Identifier: NCT02939950|
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: samfilcon A soft contact lenses Device: PureVision contact lenses||Not Applicable|
Approximately 816 subjects (1,632 eyes) will be enrolled in this 12-month randomized, parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the US.
At the Screening/Dispensing Visit, approximately one-half of the subjects will be randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up Visits to maintain a monthly replacement schedule. Subjects will also be required to complete a paper diary.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||816 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: samfilcon A Ultra Contact Lenses
Bausch + Lomb investigational samfilcon A soft contact lenses (Test) Ultra Contact Lenses
Device: samfilcon A soft contact lenses
soft contact lenses
Active Comparator: PureVision contact lenses
Bausch + Lomb PureVision contact lenses
Device: PureVision contact lenses
- Primary Safety Analysis - Adverse Events [ Time Frame: one year ]new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® contact lens when worn for 7-day extended wear by adapted soft contact lens wearers, and must report all adverse events during study participation and must be followed until the event resolves or stabilizes.
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): NCT02939950
|United States, New York|
|Cicero Family Eye Care|
|Cicero, New York, United States, 13039|
|Study Director:||Johnson Varughese||Bausch Health Americas, Inc.|