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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOV03 4 times daily (QID) | Experimental | 100% Perfluorohexyloctance solution 4 times daily (QID) |
|
| Placebo 4 times daily (QID) | Placebo Comparator | Saline solution (0.6% sodium chloride solution) 4 times daily (QID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOV03 | Drug | 100% Perfluorohexyloctane |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at 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. | Assessed from Baseline to Day 57 |
| Change From Baseline of Dryness Score at 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). | Assessed from Baseline to Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 124 | Birmingham | Alabama | 35233 | United States | ||
| Bausch Site 125 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39564145 | Derived | Fahmy AM, Harthan JS, Evans DG, Greiner JV, Tauber J, Sheppard JD, Krosser S, Vittitow JL. Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials. Front Ophthalmol (Lausanne). 2024 Nov 5;4:1452422. doi: 10.3389/fopht.2024.1452422. eCollection 2024. | |
| 36729473 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | NOV03 4 Times Daily (QID) | 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane |
| FG001 | Placebo 4 Times Daily (QID) | Saline solution (0.6% sodium chloride solution) 4 times daily (QID) Placebo: Saline solution (0.6% sodium chloride solution) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2020 | Aug 23, 2024 |
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| Drug |
Saline solution (0.6% sodium chloride solution) |
|
| Scottsdale |
| Arizona |
| 85254 |
| United States |
| Bausch Site 110 | Glendale | California | 91204 | United States |
| Bausch Site 121 | Long Beach | California | 90805 | United States |
| Bausch Site 102 | Mission Hills | California | 91345 | United States |
| Bausch Site 101 | Newport Beach | California | 92663 | United States |
| Bausch Site 116 | Rancho Cordova | California | 95670 | United States |
| 103 | Torrance | California | 90505 | United States |
| Bausch Site 123 | Torrance | California | 90505 | United States |
| Bausch Site 127 | Danbury | Connecticut | 06810 | United States |
| Bausch Site 129 | Fort Myers | Florida | 33901 | United States |
| Bausch Site 115 | Jacksonville | Florida | 32256 | United States |
| Bausch Site 106 | Largo | Florida | 33773 | United States |
| Bausch Site 117 | Tampa | Florida | 33603 | United States |
| Bausch Site 108 | Lake Villa | Illinois | 60046 | United States |
| Bausch Site 112 | Indianapolis | Indiana | 46260 | United States |
| Bausch Site 119 | Edgewood | Kentucky | 41017 | United States |
| Bausch Site 126 | Winchester | Massachusetts | 01890 | United States |
| Bausch Site 113 | Kansas City | Missouri | 64111 | United States |
| Bausch Site 111 | St Louis | Missouri | 63131 | United States |
| Bausch Site 128 | Slingerlands | New York | 12159 | United States |
| Bausch Site 114 | Raleigh | North Carolina | 27603 | United States |
| Bausch Site 122 | Cranberry Township | Pennsylvania | 16066 | United States |
| Bausch Site 107 | Memphis | Tennessee | 38119 | United States |
| Bausch Site 109 | Nashville | Tennessee | 37205 | United States |
| Bausch Site 120 | El Paso | Texas | 79902 | United States |
| Bausch Site 104 | Lakeway | Texas | 78738 | United States |
| Bausch Site 105 | Round Rock | Texas | 78681 | United States |
| Bausch Site 118 | San Antonio | Texas | 78229 | United States |
| Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NOV03 4 Times Daily (QID) | 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane |
| BG001 | Placebo 4 Times Daily (QID) | Saline solution (0.6% sodium chloride solution) 4 times daily (QID) Placebo: Saline solution (0.6% sodium chloride solution) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed from Baseline to Day 57 | Eyes | Eyes |
|
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline of Dryness Score at 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). | Posted | Mean | Standard Deviation | units on a scale | Assessed from Baseline to Day 57 | Eyes | Eyes |
|
|
Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NOV03 4 Times Daily (QID) | 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane | 0 | 303 | 0 | 303 | 16 | 303 |
| EG001 | Placebo 4 Times Daily (QID) | Saline solution (0.6% sodium chloride solution) 4 times daily (QID) Placebo: Saline solution (0.6% sodium chloride solution) | 0 | 294 | 0 | 294 | 11 | 294 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | Non-systematic Assessment |
| ||
| Instillation site pain | Eye disorders | Non-systematic Assessment |
| ||
| Conjunctival haemorrhage | Eye disorders | Non-systematic Assessment |
| ||
| Eye discharge | Eye disorders | Non-systematic Assessment |
| ||
| Punctate keratitis | Eye disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Donatello | Bausch & Lomb | 5853385306 | Daniel.Donatello@bausch.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2020 | Aug 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Eyes |
|
|