Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses
- Conditions
- Refractive Errors
- Interventions
- Device: Verofilcon A spherical soft contact lensesDevice: Verofilcon A toric soft contact lenses
- Registration Number
- NCT06462456
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.
- Detailed Description
This study consists of a Baseline Visit and a Year 1 Visit.
The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a PRECISION1™ sphere or toric contact lens prescription was released. The Baseline Visit will be retrospective, with all assessments obtained from chart review.
The Year 1 Visit is defined as the visit that occurs 1 year (-2/+4 months) since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit. The Year 1 Visit may be prospective or retrospective.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 168
- Subject (or subject's legal representative) is able to understand and sign an informed consent/assent form approved by an Institutional Review Board (IRB), unless appropriate consent waiver for the retrospective chart review is provided by the IRB.
- Verofilcon A (sphere or toric) contact lens wear as described in the protocol.
- Best corrected spectacle distance visual acuity (VA) 20/25 or better at baseline.
- Healthy, non-diseased eyes, as determined/known by the Investigator.
- Other protocol-defined inclusion criteria may apply.
Key
- Any ocular disease or condition that would contraindicate contact lens wear present at baseline.
- Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PRECISION1 Sphere Verofilcon A spherical soft contact lenses Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting PRECISION1 Toric Verofilcon A toric soft contact lenses Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting
- Primary Outcome Measures
Name Time Method Incidence of Microbial Keratitis Up to Year 1 Microbial keratitis is a sight-threatening infection of the cornea.
Distance Visual Acuity with Study Lenses at Year 1 Follow-Up Year 1 Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Distance Visual Acuity with Study Lenses at Baseline Baseline Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Incidence of Corneal Infiltrative Events Up to Year 1 A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Scripps Optometric Group
🇺🇸San Diego, California, United States
Pearle Vision
🇺🇸Jacksonville, Florida, United States
Vision Health Institute
🇺🇸Orlando, Florida, United States
Vision Salon Eye Care Associates
🇺🇸Blue Island, Illinois, United States
Illinois College of Optometry
🇺🇸Chicago, Illinois, United States
CORL, Indiana University
🇺🇸Bloomington, Indiana, United States
The Eye Doctors Inc
🇺🇸Eden Prairie, Minnesota, United States
Cornea and Contact Lens Institute of Minnesota
🇺🇸Edina, Minnesota, United States
Complete Eye Care of Medina
🇺🇸Medina, Minnesota, United States
Spectrum Eyecare
🇺🇸Jamestown, New York, United States
Eyecare Professionals, Inc
🇺🇸Powell, Ohio, United States
Optometry Group, PLLC
🇺🇸Memphis, Tennessee, United States