Clinical trial NCT06462456: Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses
Official title: Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical Soft Contact Lenses (Verofilcon A) and PRECISION1T™ for Astigmatism Contact Lenses (Verofilcon A)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Refractive Errors
Keywords: Myopia
Hyperopia
Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 168
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from clinical sites located in the United States.

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.

Eligibility 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 exclusion criteria may apply.

Primary outcomes:
measure: Distance Visual Acuity with Study Lenses at Baseline
timeFrame: Baseline
measure: Distance Visual Acuity with Study Lenses at Year 1 Follow-Up
timeFrame: Year 1
measure: Incidence of Corneal Infiltrative Events
timeFrame: Up to Year 1
measure: Incidence of Microbial Keratitis
timeFrame: Up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Optometric Group
state: California
city: Jacksonville
country: United States
facility: Pearle Vision
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Blue Island
country: United States
facility: Vision Salon Eye Care Associates
state: Illinois
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Bloomington
country: United States
facility: CORL, Indiana University
state: Indiana
city: Eden Prairie
country: United States
facility: The Eye Doctors Inc
state: Minnesota
city: Edina
country: United States
facility: Cornea and Contact Lens Institute of Minnesota
state: Minnesota
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Jamestown
country: United States
facility: Spectrum Eyecare
state: New York
city: Powell
country: United States
facility: Eyecare Professionals, Inc
state: Ohio
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, VC
role: STUDY_DIRECTOR
References: