Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

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

Phase

N/A

Condition

Eye Disorders/infections

Treatment

Comfilcon A multifocal soft contact lenses

Lotrafilcon B multifocal soft contact lenses

Clinical Study ID

NCT05886894
CLJ241-N003
  • Ages > 40
  • 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 plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or extended (overnight) wear.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye atbaseline;

  • Must have worn or be wearing Air Optix plus Hydraglyde Multifocal or BiofinityMultifocal for at least 1 year in a daily wear modality, or 3 years in an extendedwear modality;

  • 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;

  • Participation of the patient in a contact lens or contact lens care product trialduring the period of the retrospective chart collection;

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 340
Treatment Group(s): 2
Primary Treatment: Comfilcon A multifocal soft contact lenses
Phase:
Study Start date:
August 08, 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. 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/charts meeting the eligibility criteria will be enrolled in the study.

Connect with a study center

  • Complete Family Vision Care

    San Diego, California 92123
    United States

    Site Not Available

  • Pearle Vision

    Jacksonville, Florida 32246
    United States

    Site Not Available

  • Jackson Health Community Center

    Miami, Florida 33126
    United States

    Site Not Available

  • 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

  • Sacco Eye Group

    Vestal, New York 13850
    United States

    Site Not Available

  • Smith Bowman Ophthalmology

    Salt Lake City, Utah 84117
    United States

    Site Not Available

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