Air Optix Daily Wear Contact Lenses

NCT ID: NCT05827224

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 312 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-07-17

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.

Conditions

Refractive Errors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Air Optix Aqua Sphere

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

Lotrafilcon B spherical soft contact lenses

Intervention Type: DEVICE

Commercially available silicone hydrogel 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

Lotrafilcon B spherical soft contact lenses with comfort additive

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lenses

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

Lotrafilcon B toric soft contact lenses with comfort additive

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lenses

Biofinity Sphere

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

Comfilcon A spherical soft contact lenses

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lenses

Biofinity Toric

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

Comfilcon A toric soft contact lenses

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lenses

Interventions

Lotrafilcon B spherical soft contact lenses

Commercially available silicone hydrogel contact lenses

Intervention Type: DEVICE

Lotrafilcon B spherical soft contact lenses with comfort additive

Commercially available silicone hydrogel contact lenses

Intervention Type: DEVICE

Lotrafilcon B toric soft contact lenses with comfort additive

Commercially available silicone hydrogel contact lenses

Intervention Type: DEVICE

Comfilcon A spherical soft contact lenses

Commercially available silicone hydrogel contact lenses

Intervention Type: DEVICE

Comfilcon A toric soft contact lenses

Commercially available silicone hydrogel contact lenses

Intervention Type: DEVICE

Other Intervention Names

Air Optix® Aqua Sphere; Air Optix® plus HydraGlyde® Sphere; Air Optix® plus HydraGlyde® Toric; Biofinity Sphere; Biofinity Toric

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 1 year in a daily wear modality, as determined by the Investigator;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Vision Health Institute

Orlando, Florida, United States

Complete Eye Care of Medina

Medina, Minnesota, United States

Koetting Associates

St Louis, Missouri, United States

Toyos Clinic

Nashville, Tennessee, United States

Smith Bowman Ophthalmology

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

CLJ241-N001

Identifier Type: -

Identifier Source: org_study_id