Air Optix Extended Wear Contact Lenses

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Lotrafilcon B spherical soft contact lenses; Device: Lotrafilcon B spherical soft contact lenses with comfort additive; Device: Lotrafilcon B toric soft contact lenses with comfort additive; Device: Comfilcon A spherical soft contact lenses; Device: Comfilcon A toric soft contact lenses

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 Type: Observational
• Enrollment (Estimated): 640

Contacts and Locations

• Study Contact: Name: Alcon Call Center; Phone Number: 1-888-451-3937; Email: medinfo.alcon@alcon.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Koetting Associates
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Smith Bowman Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Air Optix Aqua Sphere; 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).	Device: Lotrafilcon B spherical soft contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Air Optix® Aqua Sphere
Air Optix plus HydraGlyde Sphere; 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).	Device: Lotrafilcon B spherical soft contact lenses with comfort additive; Commercially available silicone hydrogel contact lenses; Other Names: Air Optix® plus HydraGlyde® Sphere
Air Optix plus HydraGlyde Toric; 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).	Device: Lotrafilcon B toric soft contact lenses with comfort additive; Commercially available silicone hydrogel contact lenses; Other Names: Air Optix® plus HydraGlyde® Toric
Biofinity Sphere; 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).	Device: Comfilcon A spherical soft contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity Sphere
Biofinity Toric; 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).	Device: Comfilcon A toric soft contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of corneal infiltrative events	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.	Up to Year 3
Incidence of microbial keratitis	The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.	Up to Year 3
Distance visual acuity (VA) with study lenses at 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.	Year 1
Distance visual acuity (VA) with study lenses at 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.	Year 3

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLJ241-N002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No