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The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Tavilermide ophthalmic solution | Experimental |
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| 5% Tavilermide ophthalmic solution | Experimental |
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| Vehicle ophthalmic solution | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavilermide ophthalmic solution | Drug | BID topical dosing |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eye Dryness Score as Measured by the VAS | The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm. | Baseline to Day 85 in 5% Tavilermide versus Placebo |
| Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior) . Grade 0 was specified when no staining is present. The maximum score was 15. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline. | Baseline to Day 85 in 5% Tavilermide versus Placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Meerovitch, PhD | Mimetogen Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tavilermide Investigational Site | Phoenix | Arizona | 85032 | United States | ||
| Tavilermide Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tavilermide 5% | Twice daily topical ocular dosing for 12 weeks |
| FG001 | Tavilermide 1% | Twice daily topical ocular dosing for 12 weeks |
| 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 | Jul 3, 2019 | Feb 9, 2023 |
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| Placebo | Other | BID topical dosing |
|
| Los Angeles |
| California |
| 90013 |
| United States |
| Tavilermide Investigational Site | Newport Beach | California | 92663 | United States |
| Tavilermide Investigational Site | Fort Collins | Colorado | 80528 | United States |
| Tavilermide Investigational Site | Littleton | Colorado | 80120 | United States |
| Tavilermide Investigational Site | Boynton Beach | Florida | 33437 | United States |
| Tavilermide Investigational Site | Bradenton | Florida | 34209 | United States |
| Tavilermide Investigational Site | Coral Springs | Florida | 33067 | United States |
| Tavilermide Investigational Site | Ocala | Florida | 34474 | United States |
| Tavilermide Investigational Site | Indianapolis | Indiana | 46290 | United States |
| Tavilermide Investigational Site | Sioux City | Iowa | 51104 | United States |
| Tavilermide Investigational Site | Lexington | Kentucky | 40509 | United States |
| Tavilermide Investigational Site | Louisville | Kentucky | 40206 | United States |
| Tavilermide Investigational Site | St Louis | Missouri | 63131 | United States |
| Tavilermide Investigational Site | Shelby | North Carolina | 28150 | United States |
| Tavilermide Investigational Site | Cincinnati | Ohio | 45236 | United States |
| Tavilermide Investigational Site | Mason | Ohio | 45040 | United States |
| Tavilermide Investigational Site | Rapid City | South Dakota | 57701 | United States |
| Tavilermide Investigational Site | Maryville | Tennessee | 37803 | United States |
| Tavilermide Investigational Site | Nashville | Tennessee | 37205 | United States |
| Tavilermide Investigational Site | San Antonio | Texas | 78248 | United States |
| Tavilermide Investigational Site | Kenosha | Wisconsin | 53142 | United States |
| FG002 | Placebo | Twice daily topical ocular dosing for 12 weeks (vehicle) |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) set included all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Tavilermide 5% | Tavilermide ophthalmic solution: BID topical dosing |
| BG001 | Tavilermide 1% | Tavilermide ophthalmic solution: BID topical dosing |
| BG002 | Vehicle | Placebo: BID topical dosing |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Eye Dryness Score | Visual Analog Scale (0 to 100 Scale, Higher is Worse) | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Total Corneal Fluorescein Staining | National Eye Institute Scale (0 to 15, Higher is Worse) | Mean | Standard Deviation | units on a scale |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Eye Dryness Score as Measured by the VAS | The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm. | ITT Population with Markov Chain Monte Carlo (MCMC) on all randomized subjects | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 85 in 5% Tavilermide versus Placebo |
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| Primary | Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior) . Grade 0 was specified when no staining is present. The maximum score was 15. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline. | ITT Population with MCMC on all randomized subjects | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 85 in 5% Tavilermide versus Placebo |
|
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12 weeks
Adverse event collection was on the safety population which included all randomized subjects who received at least one dose of the investigational product.
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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 | Tavilermide 5% | Twice daily topical dosing | 1 | 261 | 2 | 261 | 16 | 261 |
| EG001 | Tavilermide 1% | Twice daily topical dosing | 0 | 99 | 0 | 99 | 1 | 99 |
| EG002 | Placebo | Twice daily topical dosing (vehicle) | 0 | 255 | 3 | 255 | 8 | 255 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA (22.0) | Systematic Assessment |
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Sponsor, or its designee, shall have the right to coordinate one or more publications of the aggregate multi-site Study results. Accordingly, Investigator agrees not to publish or present the results of the Study until such time as the aggregate multi-site Study results are published.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Development | Mimetogen Pharmaceuticals | 514 924 7484 | karen.meerovitch@mimetogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2020 | Feb 9, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D007766 | Lacrimal Apparatus 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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