Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
- Registration Number
- NCT04139798
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 599
- 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 and Visit 1
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description NOV03 4 times daily (QID) NOV03 100% Perfluorohexyloctance solution 4 times daily (QID) Placebo 4 times daily (QID) Placebo Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
- Primary Outcome Measures
Name Time Method Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57 Assessed from Baseline to Day 57 Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Change From Baseline of Dryness Score at Day 57 Assessed from Baseline to Day 57 Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Bausch Site 112
🇺🇸Indianapolis, Indiana, United States
103
🇺🇸Torrance, California, United States
Bausch Site 115
🇺🇸Jacksonville, Florida, United States
Bausch Site 108
🇺🇸Lake Villa, Illinois, United States
Bausch Site 122
🇺🇸Cranberry Township, Pennsylvania, United States
Bausch Site 102
🇺🇸Mission Hills, California, United States
Bausch Site 110
🇺🇸Glendale, California, United States
Bausch Site 104
🇺🇸Lakeway, Texas, United States
Bausch Site 107
🇺🇸Memphis, Tennessee, United States
Bausch Site 128
🇺🇸Slingerlands, New York, United States
Bausch Site 114
🇺🇸Raleigh, North Carolina, United States
Bausch Site 124
🇺🇸Birmingham, Alabama, United States
Bausch Site 125
🇺🇸Scottsdale, Arizona, United States
Bausch Site 101
🇺🇸Newport Beach, California, United States
Bausch Site 121
🇺🇸Long Beach, 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 106
🇺🇸Largo, Florida, United States
Bausch Site 117
🇺🇸Tampa, Florida, United States
Bausch Site 126
🇺🇸Winchester, Massachusetts, United States
Bausch Site 113
🇺🇸Kansas City, Missouri, United States
Bausch Site 119
🇺🇸Edgewood, Kentucky, United States
Bausch Site 111
🇺🇸Saint Louis, Missouri, United States
Bausch Site 120
🇺🇸El Paso, Texas, United States
Bausch Site 105
🇺🇸Round Rock, Texas, United States
Bausch Site 116
🇺🇸Rancho Cordova, California, United States
Bausch Site 109
🇺🇸Nashville, Tennessee, United States
Bausch Site 118
🇺🇸San Antonio, Texas, United States