Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses

Refractive Errors Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462456
• Other study ID #: CLE383-I001
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Refractive Errors

Intervention

Device:
• Verofilcon 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)
• Verofilcon A toric 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) with astigmatism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity with Study Lenses at Baseline	Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.	Baseline
Primary	Distance Visual Acuity with Study Lenses at Year 1 Follow-Up	Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.	Year 1
Primary	Incidence of Corneal Infiltrative Events	A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.	Up to Year 1
Primary	Incidence of Microbial Keratitis	Microbial keratitis is a sight-threatening infection of the cornea.	Up to Year 1