Clinical trial NCT05827224: Air Optix Daily Wear Contact Lenses
Official title: Air Optix Daily Wear Contact Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
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 Aqua, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as daily 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 meeting the eligibility criteria will be enrolled in the study.

Eligibility criteria: Key Inclusion Criteria:

* Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);
* Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
* Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 1 year in a daily wear modality, as determined by the Investigator;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere, or Biofinity Toric contact lenses in an extended wear modality;
* 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;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Distance visual acuity (VA) with study lenses
timeFrame: Up to Year 1
measure: Incidence of corneal infiltrative events
timeFrame: Up to Year 1
measure: Incidence of microbial keratitis
timeFrame: Up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
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: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
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: