Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)

Completed · Phase 3

Conditions studied: Dry Eye Disease (DED)

In brief

The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Key facts

Study ID

NCT04140227

Run by

Bausch & Lomb Incorporated

People needed

256

Starts

2020-09-24

Expected to finish

2022-01-05

Last updated by the study team

2024-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 study assessments and visits

You may not qualify if…

• Women who are pregnant, nursing or planning pregnancy
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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