Clinical trial NCT05886894: Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses
Official title: Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Refractive Errors
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 340
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will enroll charts following a pre-identified process.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Distance visual acuity at 1 year - Daily Wear
timeFrame: Year 1
measure: Near visual acuity at 1 year - Daily Wear
timeFrame: Year 1
measure: Distance visual acuity at 3 years - Extended Wear
timeFrame: Year 3
measure: Near visual acuity at 3 years - Extended Wear
timeFrame: Year 3
measure: Incidence of corneal infiltrative events - Daily Wear
timeFrame: Up to Year 1
measure: Incidence of corneal infiltrative events - Extended Wear
timeFrame: Up to Year 3
measure: Incidence of microbial keratitis - Daily Wear
timeFrame: Up to Year 1
measure: Incidence of microbial keratitis - Extended Wear
timeFrame: Up to Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Complete Family Vision Care
state: California
city: Jacksonville
country: United States
facility: Pearle Vision
state: Florida
city: Miami
country: United States
facility: Jackson Health Community Center
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Saint Louis
country: United States
facility: Koetting Associates
state: Missouri
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Salt Lake City
country: United States
facility: Smith Bowman Ophthalmology
state: Utah
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: