Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Test
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
- Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
- Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
- Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria:
- Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
- Subject has systemic disease affecting ocular health.
- Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
- Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
- Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
Sites / Locations
- Bausch Site 117
- Bausch Site 107
- Bausch Site 101
- Bausch Site 108
- Bausch Site 104
- Bausch Site 102
- Bausch Site 116
- Bausch Site 110
- Bausch Site 118
- Bausch Site 111
- Bausch Site 114
- Bausch Site 105
- Bausch Site 115
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test
Control
Arm Description
Soft Contact Lens
Contact lens
Outcomes
Primary Outcome Measures
Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better
The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes
Secondary Outcome Measures
Full Information
NCT ID
NCT03681808
First Posted
September 20, 2018
Last Updated
January 6, 2021
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT03681808
Brief Title
Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
Official Title
A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).
Detailed Description
This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Masking
Investigator
Masking Description
Subjects will be dispensed product according to the treatment arm corresponding to their randomization and will be unmasked. The Investigator will be masked.
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Soft Contact Lens
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Contact lens
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Contact Lens
Intervention Type
Device
Intervention Name(s)
Test
Intervention Description
Soft Contact Lens
Primary Outcome Measure Information:
Title
Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better
Description
The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes
Time Frame
Evaluated at the 1 week follow up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria:
Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
Subject has systemic disease affecting ocular health.
Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Mathew
Organizational Affiliation
Bausch Health Companies
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 117
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Bausch Site 107
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Bausch Site 101
City
San Francisco
State/Province
California
ZIP/Postal Code
94112
Country
United States
Facility Name
Bausch Site 108
City
San Jose
State/Province
California
ZIP/Postal Code
95132
Country
United States
Facility Name
Bausch Site 104
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94087
Country
United States
Facility Name
Bausch Site 102
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Bausch Site 116
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Bausch Site 110
City
Brighton
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Bausch Site 118
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Bausch Site 111
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Bausch Site 114
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Bausch Site 105
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
Bausch Site 115
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
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