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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-30

Study Completion Date

2025-03-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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PRECISION1 Sphere

Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting

Verofilcon A spherical soft contact lenses

Intervention Type DEVICE

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)

PRECISION1 Toric

Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting

Verofilcon A toric soft contact lenses

Intervention Type DEVICE

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

Interventions

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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)

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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PRECISION1™ PRECISION1™ for Astigmatism

Eligibility Criteria

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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.

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.

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No