TerminatedNot Applicable

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

Stopped: Management decision

United States140 participantsStarted 2024-08-30

Plain-language 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.

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Distance Visual Acuity with Study Lenses at Baseline

Timeframe: Baseline

Distance Visual Acuity with Study Lenses at Year 1 Follow-Up

Timeframe: Year 1

Incidence of Corneal Infiltrative Events

Timeframe: Up to Year 1

Incidence of Microbial Keratitis

Timeframe: Up to Year 1

Trial details

NCT IDNCT06462456

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-11

View on ClinicalTrials.gov More Refractive Errors trials

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.