Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
- Conditions
- Refractive ErrorsAstigmatismAmetropia
- Interventions
- Device: Verofilcon A toric contact lensesDevice: Etafilcon A toric contact lenses
- Registration Number
- NCT04908488
- Lead Sponsor
- Alcon Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description P1fA, then AMfA Verofilcon A toric contact lenses 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. P1fA, then AMfA Etafilcon A toric contact lenses 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. AMfA, then P1fA Verofilcon A toric contact lenses 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. AMfA, then P1fA Etafilcon A toric contact lenses 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.
- Primary Outcome Measures
Name Time Method Least Squares Mean Distance VA (logMAR) With Study Lenses Day 8 (-0/+3 days), each study lens type 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
Name Time Method
Trial Locations
- Locations (8)
Alcon Investigator 8135
🇺🇸Los Angeles, California, United States
Alcon Investigator 8062
🇺🇸Oakland, California, United States
Alcon Investigator 6355
🇺🇸Orlando, Florida, United States
Alcon Investigator 6614
🇺🇸Franklin Park, Illinois, United States
Alcon Investigator 3382
🇺🇸Wyomissing, Pennsylvania, United States
Alcon Investigator 6353
🇺🇸Memphis, Tennessee, United States
Alcon Investigator 6645
🇺🇸Shawnee Mission, Kansas, United States
Alcon Investigator 2786
🇺🇸Memphis, Tennessee, United States