Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Primary Purpose
Refractive Errors, Ametropia, Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Kalifilcon 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:
- Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
- At least 3 months of contact lens wearing experience;
- Less than or equal to 0.75 diopter (D) astigmatism in each eye;
- Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
- Monovision and/or multifocal lens wearer;
- Routinely sleeps in habitual contact lenses.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 6355
- Alcon Investigator 6418
- Alcon Investigator 3950
- Alcon Investigator 6614
- Alcon Investigator 6583
- Alcon Investigator 3382
- Alcon Investigator 6353
- Alcon Investigator 2786
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DT1, then Infuse
Infuse, then DT1
Arm Description
Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
Outcomes
Primary Outcome Measures
Least Squares Mean Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05010512
Brief Title
Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Official Title
Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (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 DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
Detailed Description
Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Ametropia, Myopia
Keywords
Contact lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DT1, then Infuse
Arm Type
Other
Arm Description
Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
Arm Title
Infuse, then DT1
Arm Type
Other
Arm Description
Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1®, DT1
Intervention Description
Commercially available silicone hydrogel contact lenses used as indicated
Intervention Type
Device
Intervention Name(s)
Kalifilcon A contact lenses
Other Intervention Name(s)
Bausch + Lomb INFUSE™, Infuse
Intervention Description
Commercially available silicone hydrogel contact lenses used as indicated
Primary Outcome Measure Information:
Title
Least Squares Mean Distance VA (logMAR) With Study Lenses
Description
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time Frame
Day 8 (-0/+3), each study lens type
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
At least 3 months of contact lens wearing experience;
Less than or equal to 0.75 diopter (D) astigmatism in each eye;
Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
Monovision and/or multifocal lens wearer;
Routinely sleeps in habitual contact lenses.
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
Alcon Investigator 6355
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Alcon Investigator 6418
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Alcon Investigator 3950
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Alcon Investigator 6614
City
Franklin Park
State/Province
Illinois
ZIP/Postal Code
60131
Country
United States
Facility Name
Alcon Investigator 6583
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Facility Name
Alcon Investigator 3382
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Alcon Investigator 6353
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Alcon Investigator 2786
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
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