Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
NCT ID: NCT02939950
Last Updated: 2019-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
816 participants
INTERVENTIONAL
2015-04-30
2016-08-03
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Bausch + Lomb Samfilcon A Soft Contact Lens
soft contact lenses
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.
Bausch + Lomb Pure Vision Soft Contact Lens
soft contact lenses
Interventions
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Bausch + Lomb Samfilcon A Soft Contact Lens
soft contact lenses
Bausch + Lomb Pure Vision Soft Contact Lens
soft contact lenses
Eligibility Criteria
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Inclusion Criteria
* Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
* Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
* Participants must have clear central corneas and be free of any anterior segment disorders.
* Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.
Exclusion Criteria
* Participants with an active ocular disease or who are using any ocular medication.
* Participants with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
* Participants who currently wear monovision, multifocal, or toric contact lenses.
18 Years
40 Years
ALL
Yes
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson Varughese
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Cicero Family Eye Care
Cicero, New York, United States
Countries
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Other Identifiers
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818
Identifier Type: -
Identifier Source: org_study_id