Clinical Comparison of Toric Contact Lenses Fit Characteristics
Not Applicable
Withdrawn
- Conditions
- AstigmatismRefractive Errors
- Interventions
- Device: Delefilcon A toric soft contact lensDevice: Lehfilcon A toric soft contact lensDevice: Lotrafilcon B toric soft contact lensDevice: Verofilcon A toric soft contact lens
- Registration Number
- NCT05805345
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.
- Detailed Description
Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
- Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
- Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
- Willing to stop wearing habitual contact lenses during in-office visits.
- Other protocol-defined inclusion criteria may apply.
Key
Exclusion Criteria
- Current spherical, monovision or multifocal lens wearer.
- Protocol-specified biomicroscopy findings at screening.
- Current or history of herpetic keratitis in either eye.
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AOHGfA/P1fA/DT1fA/T30fA Lehfilcon A toric soft contact lens AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. AOHGfA/P1fA/DT1fA/T30fA Lotrafilcon B toric soft contact lens AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. P1fA/DT1fA/T30fA/AOHGfA Lehfilcon A toric soft contact lens P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. DT1fA/T30fA/AOHGfA/P1fA Delefilcon A toric soft contact lens DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. DT1fA/T30fA/AOHGfA/P1fA Lotrafilcon B toric soft contact lens DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. T30fA/AOHGfA/P1fA/DT1fA Lotrafilcon B toric soft contact lens T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. AOHGfA/P1fA/DT1fA/T30fA Delefilcon A toric soft contact lens AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. DT1fA/T30fA/AOHGfA/P1fA Lehfilcon A toric soft contact lens DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. DT1fA/T30fA/AOHGfA/P1fA Verofilcon A toric soft contact lens DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. T30fA/AOHGfA/P1fA/DT1fA Delefilcon A toric soft contact lens T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. T30fA/AOHGfA/P1fA/DT1fA Lehfilcon A toric soft contact lens T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. T30fA/AOHGfA/P1fA/DT1fA Verofilcon A toric soft contact lens T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. AOHGfA/P1fA/DT1fA/T30fA Verofilcon A toric soft contact lens AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. P1fA/DT1fA/T30fA/AOHGfA Delefilcon A toric soft contact lens P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. P1fA/DT1fA/T30fA/AOHGfA Verofilcon A toric soft contact lens P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days. P1fA/DT1fA/T30fA/AOHGfA Lotrafilcon B toric soft contact lens P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.
- Primary Outcome Measures
Name Time Method Distance VA with study lenses 30 mins (± 15 mins), each product Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Kindred Optics at Maitland Vision
🇺🇸Maitland, Florida, United States
Kurata Eyecare Center
🇺🇸Los Angeles, California, United States
Omega Vision Center P.A.
🇺🇸Longwood, Florida, United States
Clarke EyeCare Center
🇺🇸Wichita Falls, Texas, United States
Kannarr Eye Care LLC
🇺🇸Pittsburg, Kansas, United States
ProCare Vision Centers, Inc.
🇺🇸Granville, Ohio, United States
Optometry Group, PLLC
🇺🇸Memphis, Tennessee, United States