Air Optix Daily Wear Contact Lenses

NCT05827224 | Completed FDA Device

• 1 other identifier: CLJ241-N001
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 5

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.

Conditions

Refractive Errors

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (3)

• Distance visual acuity (VA) with study lenses

  The subject's chart will be reviewed for distance visual acuity at baseline and at 1 year following the baseline exam.

  Up to Year 1

• 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 1

• Incidence of microbial keratitis

  The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.

  Up to Year 1

Study Arms (5)

Air Optix Aqua Sphere

Lotrafilcon B spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection

Device: Lotrafilcon B spherical soft contact lenses

Air Optix plus HydraGlyde Sphere

Lotrafilcon B spherical soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection

Device: Lotrafilcon B spherical soft contact lenses with comfort additive

Air Optix plus HydraGlyde Toric

Lotrafilcon B toric soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection

Device: Lotrafilcon B toric soft contact lenses with comfort additive

Biofinity Sphere

Comfilcon A spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection

Device: Comfilcon A spherical soft contact lenses

Biofinity Toric

Comfilcon A toric soft contact lenses worn in both eyes and removed daily for cleaning and disinfection

Device: Comfilcon A toric soft contact lenses

Interventions

Lotrafilcon B spherical soft contact lenses DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Air Optix® Aqua Sphere

Air Optix Aqua Sphere

Lotrafilcon B spherical soft contact lenses with comfort additive DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Air Optix® plus HydraGlyde® Sphere

Air Optix plus HydraGlyde Sphere

Lotrafilcon B toric soft contact lenses with comfort additive DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Air Optix® plus HydraGlyde® Toric

Air Optix plus HydraGlyde Toric

Comfilcon A spherical soft contact lenses DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Biofinity Sphere

Biofinity Sphere

Comfilcon A toric soft contact lenses DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Biofinity Toric

Biofinity Toric

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Koetting Associates

St Louis, Missouri, 63144, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Smith Bowman Ophthalmology

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 24, 2023
• Study Start: August 2, 2023
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)