Clinical trial NCT03925727: Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Official title: Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Dry Eye
Lead sponsor: Mimetogen Pharmaceuticals USA, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Eye Dryness Score as Measured by the VAS
timeFrame: Baseline to Day 85 in 5% Tavilermide versus Placebo
measure: Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
timeFrame: Baseline to Day 85 in 5% Tavilermide versus Placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Tavilermide Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: Tavilermide Investigational Site
state: California
city: Newport Beach
country: United States
facility: Tavilermide Investigational Site
state: California
city: Fort Collins
country: United States
facility: Tavilermide Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Tavilermide Investigational Site
state: Colorado
city: Boynton Beach
country: United States
facility: Tavilermide Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Tavilermide Investigational Site
state: Florida
city: Coral Springs
country: United States
facility: Tavilermide Investigational Site
state: Florida
city: Ocala
country: United States
facility: Tavilermide Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Tavilermide Investigational Site
state: Indiana
city: Sioux City
country: United States
facility: Tavilermide Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Tavilermide Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Tavilermide Investigational Site
state: Kentucky
city: Saint Louis
country: United States
facility: Tavilermide Investigational Site
state: Missouri
city: Shelby
country: United States
facility: Tavilermide Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Tavilermide Investigational Site
state: Ohio
city: Mason
country: United States
facility: Tavilermide Investigational Site
state: Ohio
city: Rapid City
country: United States
facility: Tavilermide Investigational Site
state: South Dakota
city: Maryville
country: United States
facility: Tavilermide Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Tavilermide Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Tavilermide Investigational Site
state: Texas
city: Kenosha
country: United States
facility: Tavilermide Investigational Site
state: Wisconsin
Study officials:
affiliation: Mimetogen Pharmaceuticals
name: Karen Meerovitch, PhD
role: STUDY_DIRECTOR
References: