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
Results First Posted : December 10, 2019
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: Bausch + Lomb Samfilcon A Soft Contact Lens Device: Bausch + Lomb Pure Vision Soft Contact Lens||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||816 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 30, 2015|
|Actual Primary Completion Date :||August 3, 2016|
|Actual Study Completion Date :||August 3, 2016|
Experimental: Bausch + Lomb Samfilcon A Soft Contact Lens
Participants will wear Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month.
Device: Bausch + Lomb Samfilcon A Soft Contact Lens
soft contact lenses
Active Comparator: Bausch + Lomb Pure Vision Soft Contact Lens
Participants will wear Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month.
Device: Bausch + Lomb Pure Vision Soft Contact Lens
soft contact lenses
- High Contrast Visual Acuity [ Time Frame: Month 12 ]For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).
- Number of Participants With Adverse Events [ Time Frame: Baseline up to Month 12 ]An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.
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.|