Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: NOV03 4 times daily (QID) 100% Perfluorohexyloctance solution 4 times daily (QID) |
Drug: NOV03
100% Perfluorohexyloctane
|
Placebo Comparator: Placebo 4 times daily (QID) Saline solution (0.6% sodium chloride solution) 4 times daily (QID) |
Drug: Placebo
Saline solution (0.6% sodium chloride solution)
|
Outcome Measures
Primary Outcome Measures
- Change from baseline (CFB) in total Corneal Fluorescein Staining (tCFS) at Day 57 [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.
- CFB of Dryness Score at Day 57 [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).
Eligibility Criteria
Criteria
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 study assessments and visits
Exclusion Criteria:
-
Women who are pregnant, nursing or planning pregnancy
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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
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Clinically significant slit-lamp findings or abnormal lid anatomy at screening and Visit 1
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Ocular/peri-ocular malignancy
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History of herpetic keratitis
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Active ocular allergies or ocular allergies that are expected to be active during the study
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Ongoing ocular or systemic infection
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Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
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Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
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Presence of uncontrolled systemic diseases
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Bausch Site 124 | Birmingham | Alabama | United States | 35233 |
2 | Bausch Site 125 | Scottsdale | Arizona | United States | 85254 |
3 | Bausch Site 110 | Glendale | California | United States | 91204 |
4 | Bausch Site 121 | Long Beach | California | United States | 90805 |
5 | Bausch Site 102 | Mission Hills | California | United States | 91345 |
6 | Bausch Site 101 | Newport Beach | California | United States | 92663 |
7 | Bausch Site 116 | Rancho Cordova | California | United States | 95670 |
8 | 103 | Torrance | California | United States | 90505 |
9 | Bausch Site 123 | Torrance | California | United States | 90505 |
10 | Bausch Site 127 | Danbury | Connecticut | United States | 06810 |
11 | Bausch Site 129 | Fort Myers | Florida | United States | 33901 |
12 | Bausch Site 115 | Jacksonville | Florida | United States | 32256 |
13 | Bausch Site 106 | Largo | Florida | United States | 33773 |
14 | Bausch Site 117 | Tampa | Florida | United States | 33603 |
15 | Bausch Site 108 | Lake Villa | Illinois | United States | 60046 |
16 | Bausch Site 112 | Indianapolis | Indiana | United States | 46260 |
17 | Bausch Site 119 | Edgewood | Kentucky | United States | 41017 |
18 | Bausch Site 126 | Winchester | Massachusetts | United States | 01890 |
19 | Bausch Site 113 | Kansas City | Missouri | United States | 64111 |
20 | Bausch Site 111 | Saint Louis | Missouri | United States | 63131 |
21 | Bausch Site 128 | Slingerlands | New York | United States | 12159 |
22 | Bausch Site 114 | Raleigh | North Carolina | United States | 27603 |
23 | Bausch Site 122 | Cranberry Township | Pennsylvania | United States | 16066 |
24 | Bausch Site 107 | Memphis | Tennessee | United States | 38119 |
25 | Bausch Site 109 | Nashville | Tennessee | United States | 37205 |
26 | Bausch Site 120 | El Paso | Texas | United States | 79902 |
27 | Bausch Site 104 | Lakeway | Texas | United States | 78738 |
28 | Bausch Site 105 | Round Rock | Texas | United States | 78681 |
29 | Bausch Site 118 | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Johnson Varughese, Bausch Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NVU-003 (Gobi)