Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
- Registration Number
- NCT04140227
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NOV03 4 times daily (QID) NOV03 100% Perfluorohexyloctance solution 4 times daily (QID)
- Primary Outcome Measures
Name Time Method Number of Participants With Ocular and Non-ocular Adverse Events 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Bausch Site 101
🇺🇸Newport Beach, California, United States
Bausch Site 123
🇺🇸Torrance, California, United States
Bausch Site 103
🇺🇸Torrance, California, United States
Bausch Site 112
🇺🇸Indianapolis, Indiana, United States
Bausch Site 118
🇺🇸San Antonio, Texas, United States
Bausch Site 127
🇺🇸Danbury, Connecticut, United States
Bausch Site 122
🇺🇸Cranberry Township, Pennsylvania, United States
Bausch Site 102
🇺🇸Mission Hills, California, United States
Bausch Site 106
🇺🇸Largo, Florida, United States
Bausch Site 107
🇺🇸Memphis, Tennessee, United States
Bausch Site 108
🇺🇸Lake Villa, Illinois, United States
Bausch Site 120
🇺🇸El Paso, Texas, United States
Bausch Site 121
🇺🇸Long Beach, California, United States
Bausch Site 115
🇺🇸Jacksonville, Florida, United States
Bausch Site 117
🇺🇸Tampa, Florida, United States
Bausch Site 124
🇺🇸Birmingham, Alabama, United States
Bausch Site 109
🇺🇸Nashville, Tennessee, United States
Bausch Site 129
🇺🇸Fort Myers, Florida, United States
Bausch Site 119
🇺🇸Edgewood, Kentucky, United States
Bausch Site 104
🇺🇸Lakeway, Texas, United States
Bausch Site 128
🇺🇸Slingerlands, New York, United States
Bausch Site 114
🇺🇸Raleigh, North Carolina, United States
Bausch Site 125
🇺🇸Scottsdale, Arizona, United States
Bausch Site 110
🇺🇸Glendale, California, United States
Bausch Site 116
🇺🇸Rancho Cordova, California, United States
Bausch Site 126
🇺🇸Winchester, Massachusetts, United States
Bausch Site 111
🇺🇸Saint Louis, Missouri, United States
Bausch Site 113
🇺🇸Kansas City, Missouri, United States