Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

Refractive Errors Clinical Trial

Official title:

Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05886894
• Other study ID #: CLJ241-N003
• Status: Enrolling by invitation
• Start date: August 8, 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. The baseline visit will be defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for the study or comparator contact lenses was released. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 340
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Lotrafilcon B multifocal soft contact lenses
Commercially available soft (hydrophilic) contact lenses indicated for the correction of presbyopia, with or without myopia or hyperopia
• Comfilcon A multifocal soft contact lenses
Commercially available soft (hydrophilic) contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia

Locations

Country	Name	City	State
United States	Pearle Vision	Jacksonville	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Jackson Health Community Center	Miami	Florida
United States	Vision Health Institute	Orlando	Florida
United States	Koetting Associates	Saint Louis	Missouri
United States	Smith Bowman Ophthalmology	Salt Lake City	Utah
United States	Complete Family Vision Care	San Diego	California
United States	Sacco Eye Group	Vestal	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance visual acuity at 1 year - Daily Wear	The subject's chart will be reviewed for distance visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).	Year 1
Primary	Near visual acuity at 1 year - Daily Wear	The subject's chart will be reviewed for near visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).	Year 1
Primary	Distance visual acuity at 3 years - Extended Wear	The subject's chart will be reviewed for distance visual acuity at Year 3, defined as the visit which occurred 3 years (-2/+8 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).	Year 3
Primary	Near visual acuity at 3 years - Extended Wear	The subject's chart will be reviewed for near visual acuity at Year 3, defined as the visit which occurred 3 years (-2/+8 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).	Year 3
Primary	Incidence of corneal infiltrative events - Daily Wear	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).	Up to Year 1
Primary	Incidence of corneal infiltrative events - Extended Wear	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).	Up to Year 3
Primary	Incidence of microbial keratitis - Daily Wear	The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).	Up to Year 1
Primary	Incidence of microbial keratitis - Extended Wear	The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).	Up to Year 3