Air Optix Extended Wear Contact Lenses

Last updated: March 11, 2025
Sponsor: Alcon Research
Overall Status: Active - Enrolling

Phase

N/A

Condition

Eye Disorders/infections

Treatment

Lotrafilcon B toric soft contact lenses with comfort additive

Comfilcon A toric soft contact lenses

Comfilcon A spherical soft contact lenses

Clinical Study ID

NCT05886881
CLJ241-N002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye atbaseline (sphere wearers only);

  • Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye atbaseline;

  • Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlydeSphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for atleast 3 years in an extended wear modality, as determined by the Investigator;

  • Other protocol-defined inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • Any recurrent history or active anterior segment infection, inflammation orabnormality contraindicating regular contact lens wear at baseline;

  • Use of systemic or ocular medications contraindicating regular contact lens wear atbaseline and/or during the period of the retrospective chart collection;

  • Slit lamp findings, including signs of pathological dry eye, that wouldcontraindicate regular contact lens wear;

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 480
Treatment Group(s): 5
Primary Treatment: Lotrafilcon B toric soft contact lenses with comfort additive
Phase:
Study Start date:
August 03, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Vision Health Institute

    Orlando, Florida 32803
    United States

    Site Not Available

  • Complete Eye Care of Medina

    Medina, Minnesota 55340
    United States

    Site Not Available

  • Koetting Associates

    Saint Louis, Missouri 63144
    United States

    Site Not Available

  • Smith Bowman Ophthalmology

    Salt Lake City, Utah 84117
    United States

    Site Not Available

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