Clinical trial NCT05886881: Air Optix Extended Wear Contact Lenses
Official title: Air Optix Extended Wear Contact Lenses
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Refractive Errors
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 480
Sex: ALL
Minimum age (years): 18
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 Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as 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. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.

Eligibility criteria: 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 3 years in an extended wear modality, as determined by the Investigator;
* 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;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Distance visual acuity (VA) with study lenses at Year 1
timeFrame: Year 1
measure: Distance visual acuity (VA) with study lenses at Year 3
timeFrame: Year 3
measure: Incidence of corneal infiltrative events
timeFrame: Up to Year 3
measure: Incidence of microbial keratitis
timeFrame: Up to Year 3
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: 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: