Refractive Errors
Conditions
Keywords
Myopia, Hyperopia, Astigmatism
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.
Interventions
DEVICEVerofilcon A spherical soft contact lenses
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia)
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Incidence of Microbial Keratitis | Up to Year 1 | Microbial keratitis is a sight-threatening infection of the cornea. |
Countries
United States
Outcome results
None listed