CompletedNot Applicable

Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

United States351 participantsStarted 2023-08-08

Plain-language summary

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or extended (overnight) wear.

Who can participate

Age range

40 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: * Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline; * Must have worn or be wearing Air Optix plus Hydraglyde Multifocal or Biofinity Multifocal for at least 1 year in a daily wear modality, or 3 years in an extended wear modality; * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline; * Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection; * Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear; * Participation of the patient in a contact lens or contact lens care product trial during the period of the retrospective chart collection; * 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 at 1 year - Daily Wear

Timeframe: Year 1

Near visual acuity at 1 year - Daily Wear

Timeframe: Year 1

Distance visual acuity at 3 years - Extended Wear

Timeframe: Year 3

Near visual acuity at 3 years - Extended Wear

Timeframe: Year 3

Incidence of corneal infiltrative events - Daily Wear

Timeframe: Up to Year 1

Incidence of corneal infiltrative events - Extended Wear

Timeframe: Up to Year 3

Incidence of microbial keratitis - Daily Wear

Timeframe: Up to Year 1

Incidence of microbial keratitis - Extended Wear

Trial details

NCT IDNCT05886894

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-20

View on ClinicalTrials.gov More Refractive Errors trials

Who can participate

Age range

40 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.

What they're measuring

Distance visual acuity at 1 year - Daily Wear

Timeframe: Year 1

Near visual acuity at 1 year - Daily Wear

Timeframe: Year 1

Distance visual acuity at 3 years - Extended Wear

Timeframe: Year 3

Near visual acuity at 3 years - Extended Wear

Timeframe: Year 3

Incidence of corneal infiltrative events - Daily Wear

Timeframe: Up to Year 1

Incidence of corneal infiltrative events - Extended Wear

Timeframe: Up to Year 3

Incidence of microbial keratitis - Daily Wear

Timeframe: Up to Year 1

Incidence of microbial keratitis - Extended Wear