Air Optix Extended Wear Contact Lenses

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

• Registration Number: NCT05886881
• 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 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.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-02
• Study Start: 2023-08-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 511

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Air Optix plus HydraGlyde Sphere	Lotrafilcon B spherical soft contact lenses with comfort additive	Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).
Biofinity Sphere	Comfilcon A spherical soft contact lenses	Comfilcon A spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).
Biofinity Toric	Comfilcon A toric soft contact lenses	Comfilcon A toric soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).
Air Optix Aqua Sphere	Lotrafilcon B spherical soft contact lenses	Lotrafilcon B spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).
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 on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Primary Outcome Measures

Name	Time	Method
Distance visual acuity (VA) with study lenses at Year 1	Year 1	The subject's chart will be reviewed for distance visual acuity at Year 1, defined as a visit which occurred 1 year (-2/+4 months) since baseline during which period the subject was wearing either the study or comparator lenses and a contact lens examination was performed. The Baseline visit is 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 lens (lotrafilcon B or comfilcon A) was released.
Distance visual acuity (VA) with study lenses at Year 3	Year 3	The subject's chart will be reviewed for distance visual acuity at Year 3, defined as a 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.
Incidence of microbial keratitis	Up to Year 3	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 3	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.

Trial Locations

Locations (4)

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

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

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

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