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This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOV03 4 times daily (QID) | Experimental | Perfluorohexyloctance solution 4 times daily (QID) |
|
| NOV03 2 times daily (BID) | Experimental | Perfluorohexyloctance solution 2 times daily (BID) |
|
| Placebo 4 times daily (QID) | Placebo Comparator | Saline solution (0.9% sodium chloride solution) 4 times daily (QID) |
|
| Placebo 2 times daily (BID) | Placebo Comparator | Saline solution (0.9% sodium chloride solution) 2 times daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOV03 | Drug | Perfluorohexyloctane |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) | The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage. | baseline and 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonja Kroesser, PhD | Novaliq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Artesia | California | 90701 | United States | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33369937 | Result | Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krosser S; SEECASE study group. A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease. Cornea. 2021 Sep 1;40(9):1132-1140. doi: 10.1097/ICO.0000000000002622. |
| Label | URL |
|---|---|
| Publication of Study Results in Cornea | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | NOV03 2 Times Daily (BID) | Perfluorohexyloctance solution 2 times daily (BID) NOV03: Perfluorohexyloctane |
| FG001 | NOV03 4 Times Daily (QID) | Perfluorohexyloctance solution 4 times daily NOV03: 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 | Dec 7, 2017 |
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| Placebo |
| Drug |
Saline solution (0.9% sodium chloride solution) |
|
| Newport Beach |
| California |
| 92660 |
| United States |
| Investigational Site | Newport Beach | California | 92663 | United States |
| Investigational Site | Santa Ana | California | 92705 | United States |
| Investigational Site | Torrance | California | 90505 | United States |
| Investigational site | Jacksonville | Florida | 32256 | United States |
| Investigational Site | Lake Villa | Illinois | 60046 | United States |
| Investigational Site | Kansas City | Missouri | 64111 | United States |
| Investigational Site | Pennington | New Jersey | 08534 | United States |
| Investigational Site | Nashville | Tennessee | 37205 | United States |
| Investigational Site | Nashville | Tennessee | 37215 | United States |
| FG002 | Placebo BID/QID | Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID) Placebo: Saline solution (0.9% sodium chloride solution) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NOV03 2 Times Daily (BID) | Perfluorohexyloctance solution 2 times daily (BID) NOV03: Perfluorohexyloctane |
| BG001 | NOV03 4 Times Daily (QID) | Perfluorohexyloctance solution 4 times daily NOV03: Perfluorohexyloctane |
| BG002 | Placebo BID/QID | Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID) Placebo: Saline solution (0.9% sodium chloride solution) |
| BG003 | 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 | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) | The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline and 2 months |
|
|
|
whole study duration (8 weeks per patient)
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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 2 Times Daily (BID) | Perfluorohexyloctance solution 2 times daily (BID) NOV03: Perfluorohexyloctane | 0 | 111 | 1 | 111 | 1 | 111 |
| EG001 | NOV03 4 Times Daily (QID) | Perfluorohexyloctance solution 4 times daily NOV03: Perfluorohexyloctane | 0 | 114 | 3 | 114 | 4 | 114 |
| EG002 | Placebo BID/QID | Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID) Placebo: Saline solution (0.9% sodium chloride solution) | 0 | 111 | 0 | 111 | 3 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulum | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Instillation site irritation | General disorders | MedDRA 20.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sonja Kroesser | Novaliq GmbH | +49 6221 50259 | 0 | info@novaliq.com |
| Apr 29, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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