Back to resultsClinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
Primary Purpose
Refractive Errors, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A toric contact lenses
Comfilcon A toric contact lenses
CLEAR CARE
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lenses
Eligibility Criteria
Key Inclusion Criteria:
- Able to understand and sign an Informed Consent form;
- Willing and able to attend all study visits as required per protocol;
- Successful wear of weekly/monthly 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 stop wearing habitual contact lenses for the duration of study participation;
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
- Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Ocular surgery within the previous 12 months or planned during the study;
- Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Habitual wear of Biofinity Toric/Biofinity Toric XR contact lenses in the 3 months prior to consent;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Sabal Eye Care
- Drs. Giedd, P.A.
- Vision Health Institute
- Kannarr Eye Care LLC
- Fischer Laser Eye Center
- SUNY College of Optometry Clinical Vision Research Center
- West Bay Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LID205255 Toric, then Biofinity Toric
Biofinity Toric, then LID205255 Toric
Arm Description
Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Outcomes
Primary Outcome Measures
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 minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05211739
Brief Title
Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
Official Title
Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
June 23, 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 clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Detailed Description
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID205255 Toric, then Biofinity Toric
Arm Type
Other
Arm Description
Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Arm Title
Biofinity Toric, then LID205255 Toric
Arm Type
Other
Arm Description
Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A toric contact lenses
Other Intervention Name(s)
LID205255 Toric
Intervention Description
FDA-cleared silicone hydrogel toric contact lenses used as indicated
Intervention Type
Device
Intervention Name(s)
Comfilcon A toric contact lenses
Other Intervention Name(s)
Biofinity Toric, CooperVision® Biofinity® Toric
Intervention Description
Commercially available silicone hydrogel toric contact lenses used as indicated
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Intervention Description
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Primary Outcome Measure Information:
Title
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 minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
Time Frame
Day 1 and Day 30, each wear period (approximately 30 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Successful wearers of weekly/monthly 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;
Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
Able to wear contact lenses within the range of available sphere & cylinder power and axes.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Daily disposable contact lens wearers.
Monovision and multifocal contact lens wearers.
Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, CRD Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Sabal Eye Care
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Drs. Giedd, P.A.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Vision Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Kannarr Eye Care LLC
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Fischer Laser Eye Center
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
SUNY College of Optometry Clinical Vision Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
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