Clinical trial NCT05848128: Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Official title: A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Dry Eye Disease
Kerato Conjunctivitis Sicca
Lead sponsor: Mimetogen Pharmaceuticals USA, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-08
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.


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 Total Corneal Fluorescein Staining as Measured by the NEI Scale
timeFrame: Baseline to Day 85
measure: Change From Baseline in Eye Dryness Score as Measured by the VAS
timeFrame: Baseline to Day 85
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Eye Doctors of Arizona
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye & Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Atlanta
country: United States
facility: Eye Consultants of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Rochester
country: United States
facility: Rochester Ophthalmological Group
state: New York
city: Garner
country: United States
facility: Oculus Research
state: North Carolina
city: Winston-Salem
country: United States
facility: James D. Branch
state: North Carolina
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates
state: Pennsylvania
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: Houston
country: United States
facility: Advanced Laser Vision & Surgical Institute
state: Texas
city: Lakeway
country: United States
facility: Lake Travis Eye & Laser Center/Revolution Research
state: Texas
city: San Antonio
country: United States
facility: PNV Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
References: