Back to resultsSilicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bausch + Lomb Samfilcon A Soft Contact Lens
Bausch + Lomb Pure Vision Soft Contact Lens
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
- 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 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.
- 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.
Sites / Locations
- Cicero Family Eye Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bausch + Lomb Samfilcon A Soft Contact Lens
Bausch + Lomb Pure Vision Soft Contact Lens
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
High Contrast Visual Acuity
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02939950
First Posted
June 1, 2015
Last Updated
December 9, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02939950
Brief Title
Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 30, 2015 (Actual)
Primary Completion Date
August 3, 2016 (Actual)
Study Completion Date
August 3, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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® 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
816 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bausch + Lomb Samfilcon A Soft Contact Lens
Arm Type
Experimental
Arm Description
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.
Arm Title
Bausch + Lomb Pure Vision Soft Contact Lens
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bausch + Lomb Samfilcon A Soft Contact Lens
Intervention Description
soft contact lenses
Intervention Type
Device
Intervention Name(s)
Bausch + Lomb Pure Vision Soft Contact Lens
Intervention Description
soft contact lenses
Primary Outcome Measure Information:
Title
High Contrast Visual Acuity
Description
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).
Time Frame
Month 12
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
Baseline up to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
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 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson Varughese
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cicero Family Eye Care
City
Cicero
State/Province
New York
ZIP/Postal Code
13039
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
We'll reach out to this number within 24 hrs