Back to resultsClinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
Primary Purpose
Refractive Errors, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verofilcon A toric contact lenses
Stenfilcon A toric contact lenses
Sponsored by
About this trial
This is an interventional other trial for Refractive Errors focused on measuring Contact lenses, Daily disposable
Eligibility Criteria
Key Inclusion Criteria:
- Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
- Current wear of spherical contact lenses.
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 6565
- Alcon Investigator 6567
- Alcon Investigator 8097
- Alcon Investigator 6313
- Alcon Investigator 6401
- Alcon Investigator 6353
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
P1fA, then MyDay Toric
MyDay Toric, then P1fA
Arm Description
Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
Outcomes
Primary Outcome Measures
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05039112
Brief Title
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
Official Title
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.
Detailed Description
Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Astigmatism
Keywords
Contact lenses, Daily disposable
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P1fA, then MyDay Toric
Arm Type
Other
Arm Description
Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
Arm Title
MyDay Toric, then P1fA
Arm Type
Other
Arm Description
Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product 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, used as indicated
Intervention Type
Device
Intervention Name(s)
Stenfilcon A toric contact lenses
Other Intervention Name(s)
MyDay Toric
Intervention Description
Soft contact lenses for optical correction of astigmatism, used as indicated
Primary Outcome Measure Information:
Title
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion
Description
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Time Frame
Day 1, 10 minutes after lens insertion, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
Current wear of spherical contact lenses.
Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
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 6565
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigator 6567
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Alcon Investigator 8097
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Alcon Investigator 6313
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigator 6401
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Alcon Investigator 6353
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
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