Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

Last updated: February 17, 2025
Sponsor: Alcon Research
Overall Status: Completed

Phase

N/A

Condition

Sjogren's Syndrome

Dry Eye Disease

Dry Eyes

Treatment

FID123300 ocular lubricant

Clinical Study ID

NCT06444516
DEP918-C001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Willing and able to understand and sign an approved informed consent form.

  • Exhibit symptoms of dry eye at the Screening visit.

  • Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye atthe Screening visit.

  • Willing to discontinue use of all artificial tear supplements and use only the studyproduct as directed starting at Visit 2/Day 1.

  • Other protocol-defined inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • Pregnant, breastfeeding, or planning to become pregnant during the study.

  • Ocular abnormalities that could adversely affect the safety or efficacy outcome.

  • Uncontrolled active systemic diseases.

  • Use of systemic medications known to cause dry eye.

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 161
Treatment Group(s): 1
Primary Treatment: FID123300 ocular lubricant
Phase:
Study Start date:
September 04, 2024
Estimated Completion Date:
February 07, 2025

Study Description

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Connect with a study center

  • Lee Shettle Eye

    Largo, Florida 33773
    United States

    Site Not Available

  • Kindred Optics at Maitland Vision Center

    Maitland, Florida 32751
    United States

    Site Not Available

  • Vision Health Institute

    Orlando, Florida 32803
    United States

    Site Not Available

  • Franklin Park Eye Center, PC

    Franklin Park, Illinois 60131
    United States

    Site Not Available

  • Kannarr Eye Care, LLC

    Pittsburg, Kansas 66762
    United States

    Site Not Available

  • SUNY College of Optometry Clinical Vision Research Center

    New York, New York 10036
    United States

    Site Not Available

  • ProCare Vision Center

    Granville, Ohio 43023
    United States

    Site Not Available

  • Wyomissing Optometric Center

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Optometry Group, PLLC

    Memphis, Tennessee 38111
    United States

    Site Not Available

  • Clarke Eyecare Center

    Wichita Falls, Texas 76308
    United States

    Site Not Available

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