Air Optix Daily Wear Contact Lenses

Completed

• Conditions: Refractive Errors
• Interventions: Device: Lotrafilcon B spherical soft contact lenses; Device: Comfilcon A toric soft contact lenses; Device: Comfilcon A spherical soft contact lenses; Device: Lotrafilcon B spherical soft contact lenses with comfort additive; Device: Lotrafilcon B toric soft contact lenses with comfort additive

• Registration Number: NCT05827224
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-24
• Study Start: 2023-08-02
• Primary Completion: 2024-07-17
• Study Completion: 2024-07-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Air Optix Aqua Sphere	Lotrafilcon B spherical soft contact lenses	Lotrafilcon B spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection
Biofinity Toric	Comfilcon A toric soft contact lenses	Comfilcon A toric soft contact lenses worn in both eyes and removed daily for cleaning and disinfection
Biofinity Sphere	Comfilcon A spherical soft contact lenses	Comfilcon A spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection
Air Optix plus HydraGlyde Sphere	Lotrafilcon B spherical soft contact lenses with comfort additive	Lotrafilcon B spherical soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection
Air Optix plus HydraGlyde Toric	Lotrafilcon B toric soft contact lenses with comfort additive	Lotrafilcon B toric soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection

Primary Outcome Measures

Name	Time	Method
Distance visual acuity (VA) with study lenses	Up to Year 1	The subject's chart will be reviewed for distance visual acuity at baseline and at 1 year following the baseline exam.
Incidence of microbial keratitis	Up to Year 1	The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.
Incidence of corneal infiltrative events	Up to Year 1	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.

Trial Locations

Locations (5)

Toyos Clinic; 🇺🇸 Nashville, Tennessee, United States

Smith Bowman Ophthalmology; 🇺🇸 Salt Lake City, Utah, United States

Complete Eye Care of Medina; 🇺🇸 Medina, Minnesota, United States

Koetting Associates; 🇺🇸 Saint Louis, Missouri, United States

Vision Health Institute; 🇺🇸 Orlando, Florida, United States