Clinical Performance of Two Daily Disposable Soft Contact Lenses
- Conditions
- Refractive Errors
- Interventions
- Device: Verofilcon A contact lensesDevice: Nesofilcon A contact lenses
- Registration Number
- NCT05138783
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.
- Detailed Description
Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
- Other protocol-defined inclusion criteria may apply.
Key
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
- Monovision and multifocal lens wear.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PRECISION1, then Biotrue Verofilcon A contact lenses Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. PRECISION1, then Biotrue Nesofilcon A contact lenses Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. Biotrue, then PRECISION1 Verofilcon A contact lenses Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. Biotrue, then PRECISION1 Nesofilcon A contact lenses Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
- Primary Outcome Measures
Name Time Method Least Squares Mean Distance Visual Acuity (VA) With Study Lenses Day 8 (-0/+3 days), each study lens type Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Tallahassee Eye Center
🇺🇸Tallahassee, Florida, United States
Kindred Optics at Maitland Vision
🇺🇸Maitland, Florida, United States
Franklin Park Eye Center PC
🇺🇸Franklin Park, Illinois, United States
Heart of America Eye Care
🇺🇸Shawnee Mission, Kansas, United States
Complete Eye Care Of Medina
🇺🇸Medina, Minnesota, United States
ProCare Vision Centers, Inc.
🇺🇸Granville, Ohio, United States
Clarke EyeCare Center
🇺🇸Wichita Falls, Texas, United States
Stine Eye Center
🇺🇸Weston, Wisconsin, United States