TerminatedNot Applicable

Post-market Clinical Follow-up Study of Alcon TOTAL30® Contact Lenses (Lehfilcon A)

Stopped: Management decision

United States129 participantsStarted 2024-11-15

Plain-language summary

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.

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: * Wearers of lehfilcon A (sphere or toric) contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at the baseline timepoint; * Best corrected spectacle visual acuity (VA) 20/25 or better at baseline; * Healthy, non-diseased eyes; * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria, as determined or known by the Investigator: * Any ocular disease or condition that would contraindicate contact lens wear present at baseline; * The use of systemic or ocular medications that would contraindicate contact lens wear at baseline; * Participation in a contact lens or contact lens care product clinical trial during the period of the retrospective chart collection or during prospective study participation; * Other protocol-specified 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 1-year 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 IDNCT06408649

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-22

View on ClinicalTrials.gov More Ametropia 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.