Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

Last updated: October 1, 2024
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Dry Eye Disease

Eyelid Inflammation

Treatment

NOV03

Placebo

Clinical Study ID

NCT04139798
NVU-003 (Gobi)
  • Ages > 18
  • All Genders

Study Summary

This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed ICF (Informed Consent Form)

  • Subject-reported history of Drye Eye Disease (DED) in both eyes

  • Ability and willingness to follow instructions, including participation in all studyassessments and visits

Exclusion

Exclusion Criteria:

  • Women who are pregnant, nursing or planning pregnancy

  • Unwillingness to submit a blood pregnancy test at screening and the last visit (orearly termination visit) if of childbearing potential, or unwillingness to useacceptable means of birth control

  • Clinically significant slit-lamp findings or abnormal lid anatomy at screening andVisit 1

  • Ocular/peri-ocular malignancy

  • History of herpetic keratitis

  • Active ocular allergies or ocular allergies that are expected to be active duringthe study

  • Ongoing ocular or systemic infection

  • Wear contact lenses within 1 month prior to screening or anticipated use of contactlenses during the study

  • Intra-ocular surgery or ocular laser surgery within the previous 6 months, or haveplanned ocular and/or lid surgeries over the study period

  • Presence of uncontrolled systemic diseases

  • Presence of known allergy and/or sensitivity to the study drug or saline components

  • Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serumtears or topical anti-glaucoma medication within 2 months prior to screening

Study Design

Total Participants: 599
Treatment Group(s): 2
Primary Treatment: NOV03
Phase: 3
Study Start date:
July 20, 2020
Estimated Completion Date:
March 12, 2021

Connect with a study center

  • Bausch Site 124

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Bausch Site 125

    Scottsdale, Arizona 85254
    United States

    Site Not Available

  • Bausch Site 110

    Glendale, California 91204
    United States

    Site Not Available

  • Bausch Site 121

    Long Beach, California 90805
    United States

    Site Not Available

  • Bausch Site 102

    Mission Hills, California 91345
    United States

    Site Not Available

  • Bausch Site 101

    Newport Beach, California 92663
    United States

    Site Not Available

  • Bausch Site 116

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • 103

    Torrance, California 90505
    United States

    Site Not Available

  • Bausch Site 123

    Torrance, California 90505
    United States

    Site Not Available

  • Bausch Site 127

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Bausch Site 129

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Bausch Site 115

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Bausch Site 106

    Largo, Florida 33773
    United States

    Site Not Available

  • Bausch Site 117

    Tampa, Florida 33603
    United States

    Site Not Available

  • Bausch Site 108

    Lake Villa, Illinois 60046
    United States

    Site Not Available

  • Bausch Site 112

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Bausch Site 119

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Bausch Site 126

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • Bausch Site 113

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Bausch Site 111

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Bausch Site 128

    Slingerlands, New York 12159
    United States

    Site Not Available

  • Bausch Site 114

    Raleigh, North Carolina 27603
    United States

    Site Not Available

  • Bausch Site 122

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Bausch Site 107

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Bausch Site 109

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Bausch Site 120

    El Paso, Texas 79902
    United States

    Site Not Available

  • Bausch Site 104

    Lakeway, Texas 78738
    United States

    Site Not Available

  • Bausch Site 105

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Bausch Site 118

    San Antonio, Texas 78229
    United States

    Site Not Available

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