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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
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief 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® contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.

Condition or disease Intervention/treatment Phase
Myopia Device: samfilcon A soft contact lenses Device: PureVision contact lenses Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 816 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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
contact lenses




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 Logarithm of the Minimum Angle of Resolution [logMAR]) or better (distance, high contrast) in each eye.
  • Subjects must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
  • Subjects must be myopic and require lens correction from -0.50 diopters (D) to
  • 6.00 D in each eye.
  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.

Exclusion Criteria:

  • Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
  • Subjects with an active ocular disease or who are using any ocular medication.
  • Subjects 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.
  • Subjects using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
  • Subjects who currently wear monovision, multifocal, or toric contact lenses.

Information from the National Library of Medicine

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


Locations
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United States, New York
Cicero Family Eye Care
Cicero, New York, United States, 13039
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Johnson Varughese Bausch Health Americas, Inc.

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02939950     History of Changes
Other Study ID Numbers: 818
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes