Back to resultsClinical Performance of Two Daily Disposable Soft Contact Lenses
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verofilcon A contact lenses
Nesofilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lenses
Eligibility Criteria
Key Inclusion Criteria:
- Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
- Monovision and multifocal lens wear.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Kindred Optics at Maitland Vision
- Tallahassee Eye Center
- Franklin Park Eye Center PC
- Heart of America Eye Care
- Complete Eye Care Of Medina
- ProCare Vision Centers, Inc.
- Clarke EyeCare Center
- Stine Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PRECISION1, then Biotrue
Biotrue, then PRECISION1
Arm Description
Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
Outcomes
Primary Outcome Measures
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05138783
Brief Title
Clinical Performance of Two Daily Disposable Soft Contact Lenses
Official Title
Clinical Performance of Two Daily Disposable Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
March 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
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
The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.
Detailed Description
Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRECISION1, then Biotrue
Arm Type
Other
Arm Description
Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
Arm Title
Biotrue, then PRECISION1
Arm Type
Other
Arm Description
Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
Intervention Type
Device
Intervention Name(s)
Verofilcon A contact lenses
Other Intervention Name(s)
PRECISION1™
Intervention Description
Spherical soft contact lenses for daily disposable wear
Intervention Type
Device
Intervention Name(s)
Nesofilcon A contact lenses
Other Intervention Name(s)
Biotrue® ONEday
Intervention Description
Spherical soft contact lenses for daily disposable wear
Primary Outcome Measure Information:
Title
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
Description
Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time Frame
Day 8 (-0/+3 days), each study lens type
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
Monovision and multifocal lens wear.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Kindred Optics at Maitland Vision
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Tallahassee Eye Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Franklin Park Eye Center PC
City
Franklin Park
State/Province
Illinois
ZIP/Postal Code
60131
Country
United States
Facility Name
Heart of America Eye Care
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Complete Eye Care Of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
ProCare Vision Centers, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Clarke EyeCare Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76308
Country
United States
Facility Name
Stine Eye Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of Two Daily Disposable Soft Contact Lenses
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