Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
NCT ID: NCT04140227
Last Updated: 2024-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2020-09-24
2022-01-05
Brief Summary
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Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
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Detailed Description
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Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NOV03 4 times daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03
100% Perfluorohexyloctane
Interventions
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NOV03
100% Perfluorohexyloctane
Eligibility Criteria
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Inclusion Criteria
* Subject-reported history of Drye Eye Disease (DED) in both eyes
* Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion Criteria
* Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* Ocular/peri-ocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that are expected to be active during the study
* Ongoing ocular or systemic infection
* Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned 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, serum tears or topical anti-glaucoma medication within 2 months prior to screening
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson Varughese
Role: STUDY_DIRECTOR
Bausch Health
Locations
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Bausch Site 124
Birmingham, Alabama, United States
Bausch Site 125
Scottsdale, Arizona, United States
Bausch Site 110
Glendale, California, United States
Bausch Site 121
Long Beach, California, United States
Bausch Site 102
Mission Hills, California, United States
Bausch Site 101
Newport Beach, California, United States
Bausch Site 116
Rancho Cordova, California, United States
Bausch Site 103
Torrance, California, United States
Bausch Site 123
Torrance, California, United States
Bausch Site 127
Danbury, Connecticut, United States
Bausch Site 129
Fort Myers, Florida, United States
Bausch Site 115
Jacksonville, Florida, United States
Bausch Site 106
Largo, Florida, United States
Bausch Site 117
Tampa, Florida, United States
Bausch Site 108
Lake Villa, Illinois, United States
Bausch Site 112
Indianapolis, Indiana, United States
Bausch Site 119
Edgewood, Kentucky, United States
Bausch Site 126
Winchester, Massachusetts, United States
Bausch Site 113
Kansas City, Missouri, United States
Bausch Site 111
St Louis, Missouri, United States
Bausch Site 128
Slingerlands, New York, United States
Bausch Site 114
Raleigh, North Carolina, United States
Bausch Site 122
Cranberry Township, Pennsylvania, United States
Bausch Site 107
Memphis, Tennessee, United States
Bausch Site 109
Nashville, Tennessee, United States
Bausch Site 120
El Paso, Texas, United States
Bausch Site 104
Lakeway, Texas, United States
Bausch Site 118
San Antonio, Texas, United States
Countries
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References
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Protzko EE, Segal BA, Korenfeld MS, Krosser S, Vittitow JL. Long-Term Safety and Efficacy of Perfluorohexyloctane Ophthalmic Solution for the Treatment of Patients With Dry Eye Disease: The KALAHARI Study. Cornea. 2024 Sep 1;43(9):1100-1107. doi: 10.1097/ICO.0000000000003418. Epub 2023 Nov 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NVU-004 (Kalahari)
Identifier Type: -
Identifier Source: org_study_id
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