NCT02939950

Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis

A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 816 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.

Detailed description

Approximately 816 participants (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 participants 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 soft 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. Participants will also be required to complete a paper diary.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Bausch + Lomb Samfilcon A Soft Contact Lens	soft contact lenses
DEVICE	Bausch + Lomb Pure Vision Soft Contact Lens	soft contact lenses

Timeline

• Start date: 2015-04-30
• Primary completion: 2016-08-03
• Completion: 2016-08-03
• First posted: 2016-10-20
• Last updated: 2019-12-23
• Results posted: 2019-12-10

Locations

1 site across 1 country: United States