Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
Study Details
Study Description
Brief Summary
The objectives of this trial are to assess 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 100% perfluorohexyloctane 4 times daily (QID) |
Drug: NOV03
100% perfluorohexyloctane
|
| Placebo Comparator: Saline solution 0.6% sodium chloride solution 4 times daily (QID) |
Drug: Saline Solution
0.6% sodium chloride solution
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57 [Baseline, Day 57]
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
- Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57 [Baseline, Day 57]
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
Secondary Outcome Measures
- Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 15 [Baseline, Day 15]
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
- Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 15 [Baseline, Day 15]
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total of 15 points (sum of scores for each section).
- Change from baseline in burning/stinging (visual analogue scale [VAS] Severity of Burning/Stinging) at Day 57 [Baseline, Day 57]
Subjects will be asked about the severity of burning / stinging. Study staff will ask subjects to rate their ocular symptoms (both eyes simultaneously) due to ocular dryness by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no discomfort" and 100% corresponds to "maximal discomfort").
- Change from baseline in central Corneal Fluorescein Staining (NEI scale) at Day 57 [Baseline, Day 57]
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum of 3 points in the central section.
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch Site 206 | Phoenix | Arizona | United States | 85032 |
| 2 | Bausch Site 202 | Garden Grove | California | United States | 92843 |
| 3 | Bausch Site 221 | Hemet | California | United States | 92545 |
| 4 | Bausch Site 214 | Inglewood | California | United States | 90301 |
| 5 | Bausch Site 226 | Murrieta | California | United States | 92562 |
| 6 | Bausch Site 213 | Santa Ana | California | United States | 92705 |
| 7 | Bausch Site 211 | Delray Beach | Florida | United States | 33484 |
| 8 | Bausch Site 209 | Chicago | Illinois | United States | 60616 |
| 9 | Bausch Site 230 | Overland Park | Kansas | United States | 66210 |
| 10 | Bausch Site 207 | Louisville | Kentucky | United States | 40220 |
| 11 | Bausch Site 228 | Havre De Grace | Maryland | United States | 21078 |
| 12 | Bausch Site 231 | Bloomington | Minnesota | United States | 55431 |
| 13 | Bausch Site 229 | Saint Louis | Missouri | United States | 63128 |
| 14 | Bausch Site 224 | Saint Louis | Missouri | United States | 63131 |
| 15 | Bausch Site 217 | Washington | Missouri | United States | 63090 |
| 16 | Bausch Site 205 | New York | New York | United States | 10013 |
| 17 | Bausch Site 208 | Rochester | New York | United States | 14618 |
| 18 | Bausch Site 210 | Asheville | North Carolina | United States | 28803 |
| 19 | Bausch Site 201 | Cincinnati | Ohio | United States | 45247 |
| 20 | Bausch Site 216 | Cleveland | Ohio | United States | 44115 |
| 21 | Bausch Site 223 | Columbus | Ohio | United States | 43215 |
| 22 | Bausch Site 215 | Nashville | Tennessee | United States | 37215 |
| 23 | Bausch Site 219 | Cedar Park | Texas | United States | 78613 |
| 24 | Bausch Site 212 | League City | Texas | United States | 77573 |
| 25 | Bausch Site 203 | San Antonio | Texas | United States | 78213 |
| 26 | Bausch Site 222 | San Antonio | Texas | United States | 78215 |
| 27 | Bausch Site 220 | Norfolk | Virginia | United States | 23502 |
| 28 | Bausch Site 227 | Seattle | Washington | United States | 98119 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Daniel Donatello, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 904