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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOV03 4 times daily (QID) | Experimental | 100% Perfluorohexyloctance solution 4 times daily (QID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOV03 | Drug | 100% Perfluorohexyloctane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ocular and Non-ocular Adverse Events | 12 months |
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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 |
|---|---|---|---|
| 37921522 | Derived | Protzko EE, Segal BA, Korenfeld MS, Krosser S, Vittitow JL. Long-Term Safety and Efficacy of Perfluorohexyloctane Ophthalmic Solution for the Treatment of Patients With Dry Eye Disease: The KALAHARI Study. Cornea. 2024 Sep 1;43(9):1100-1107. doi: 10.1097/ICO.0000000000003418. Epub 2023 Nov 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NOV03 4 Times Daily (QID) | 100% Perfluorohexyloctance solution 4 times daily (QID) NOV03: 100% Perfluorohexyloctane |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2020 |
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| 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 |
| Bausch Site 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 118 | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm Open Label | single-arm open label |
| 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 |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Type of Eyes | 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 | Number of Participants With Ocular and Non-ocular Adverse Events | Posted | Count of Participants | Participants | 12 months |
|
|
|
AE information was captured during the duration of the study of 1 year
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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 | 1 | 208 | 10 | 208 | 44 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Gastric Cancer | Gastrointestinal disorders | Systematic Assessment |
| ||
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| hypoglcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| radius fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| ulna fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| transient ischaemic attack | Cardiac disorders | Systematic Assessment |
| ||
| schizophrenia | Psychiatric disorders | Systematic Assessment |
| ||
| spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Vitreous detachment | Eye disorders | Systematic Assessment |
| ||
| Conjuctivitis allergic | Eye disorders | Systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Instillation site pain | General disorders | Systematic Assessment |
| ||
| Hordeolum | Infections and infestations | Systematic Assessment |
| ||
| Chalazion | Eye disorders | Systematic Assessment |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese VP Clinical Services | Bausch and Lomb | 908-927-1162 | johnson.varughese@bausch.com |
| Dec 8, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| TEAE that led to Drug Withdrawal |
|