Back to resultsClinical Performance of Two Daily Disposable Toric Soft Contact Lenses
Primary Purpose
Refractive Errors, Ametropia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verofilcon A toric contact lenses
Etafilcon A toric contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lenses, Disposable
Eligibility Criteria
Inclusion Criteria:
- Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
- Any spherical monovision and multifocal lens wearers.
- Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 8135
- Alcon Investigator 8062
- Alcon Investigator 6355
- Alcon Investigator 6614
- Alcon Investigator 6645
- Alcon Investigator 3382
- Alcon Investigator 6353
- Alcon Investigator 2786
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
P1fA, then AMfA
AMfA, then P1fA
Arm Description
Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
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
NCT04908488
Brief Title
Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
Official Title
Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
September 22, 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 PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.
Detailed Description
Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation 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, Ametropia, Astigmatism
Keywords
Contact Lenses, Disposable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will receive treatment based upon the randomized treatment sequence assignment.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P1fA, then AMfA
Arm Type
Other
Arm Description
Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Arm Title
AMfA, then P1fA
Arm Type
Other
Arm Description
Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Verofilcon A toric contact lenses
Other Intervention Name(s)
PRECISION1™ for Astigmatism, P1fA
Intervention Description
Soft contact lenses for optical correction of astigmatism
Intervention Type
Device
Intervention Name(s)
Etafilcon A toric contact lenses
Other Intervention Name(s)
1-DAY ACUVUE MOIST® for ASTIGMATISM, AMfA
Intervention Description
Soft contact lenses for optical correction of astigmatism
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 days), each study lens type
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
Any spherical monovision and multifocal lens wearers.
Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
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 8135
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Alcon Investigator 8062
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Alcon Investigator 6355
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
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 6645
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
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 Daily Disposable Toric Soft Contact Lenses
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