Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1% tavilermide ophthalmic solution
|
Drug: tavilermide ophthalmic solution
BID topical dosing
|
Experimental: 5% tavilermide ophthalmic solution
|
Drug: tavilermide ophthalmic solution
BID topical dosing
|
Placebo Comparator: Vehicle ophthalmic solution
|
Other: Placebo
BID topical dosing
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in Eye Dryness Score (VAS) [Day 85]
- Change from baseline in total Corneal Fluorescein Staining [Day 85]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject-reported history of dry eye disease in both eyes for at least 6 months;
-
History of use of artificial tear eye drops for dry eye symptoms;
-
Total score of ≥40 on SANDE;
-
TFBUT;
-
Corneal fluorescein staining;
-
Lissamine green conjunctival staining;
-
Schirmer's test score.
Exclusion Criteria:
-
Have participated in a previous tavilermide (MIM-D3) study;
-
Have clinically significant slit lamp findings at Visit 1;
-
Have a history of lacrimal duct obstruction within 12 months of Visit 1;
-
Have an uncontrolled systemic disease;
-
Be a woman who is pregnant, nursing or planning a pregnancy;
-
Be a woman of childbearing potential who is not using an acceptable means of birth control;
-
Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
-
Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days prior to Visit 1.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tavilermide Investigational Site | Phoenix | Arizona | United States | 85032 |
2 | Tavilermide Investigational Site | Los Angeles | California | United States | 90013 |
3 | Tavilermide Investigational Site | Newport Beach | California | United States | 92663 |
4 | Tavilermide Investigational Site | Fort Collins | Colorado | United States | 80528 |
5 | Tavilermide Investigational Site | Littleton | Colorado | United States | 80120 |
6 | Tavilermide Investigational Site | Boynton Beach | Florida | United States | 33437 |
7 | Tavilermide Investigational Site | Bradenton | Florida | United States | 34209 |
8 | Tavilermide Investigational Site | Coral Springs | Florida | United States | 33067 |
9 | Tavilermide Investigational Site | Ocala | Florida | United States | 34474 |
10 | Tavilermide Investigational Site | Indianapolis | Indiana | United States | 46290 |
11 | Tavilermide Investigational Site | Sioux City | Iowa | United States | 51104 |
12 | Tavilermide Investigational Site | Lexington | Kentucky | United States | 40509 |
13 | Tavilermide Investigational Site | Louisville | Kentucky | United States | 40206 |
14 | Tavilermide Investigational Site | Saint Louis | Missouri | United States | 63131 |
15 | Tavilermide Investigational Site | Shelby | North Carolina | United States | 28150 |
16 | Tavilermide Investigational Site | Cincinnati | Ohio | United States | 45236 |
17 | Tavilermide Investigational Site | Mason | Ohio | United States | 45040 |
18 | Tavilermide Investigational Site | Rapid City | South Dakota | United States | 57701 |
19 | Tavilermide Investigational Site | Maryville | Tennessee | United States | 37803 |
20 | Tavilermide Investigational Site | Nashville | Tennessee | United States | 37205 |
21 | Tavilermide Investigational Site | San Antonio | Texas | United States | 78248 |
22 | Tavilermide Investigational Site | Kenosha | Wisconsin | United States | 53142 |
Sponsors and Collaborators
- Mimetogen Pharmaceuticals USA, Inc.
Investigators
- Study Director: Karen Meerovitch, PhD, Mimetogen Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIM-728