Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Dry Eye Syndromes, Dry Eye Disease, Kerato Conjunctivitis Sicca
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
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.
Sites / Locations
- Eye Doctors of ArizonaRecruiting
- Global Research ManagementRecruiting
- LoBue Laser and Eye Medical CenterRecruiting
- Eye Research FoundationRecruiting
- Nature Coast Clinical ResearchRecruiting
- Eye Associates of Fort MyersRecruiting
- Bowden Eye & AssociatesRecruiting
- Shettle Eye ResearchRecruiting
- Eye Consultants of AtlantaRecruiting
- Price Vision GroupRecruiting
- Kannarr Eye CareRecruiting
- Silverstein Eye CentersRecruiting
- Moyes Eye CenterRecruiting
- Ophthalmology AssociatesRecruiting
- Rochester Ophthalmological GroupRecruiting
- Oculus ResearchRecruiting
- James D. BranchRecruiting
- Abrams Eye CenterRecruiting
- Scott & Christie and AssociatesRecruiting
- West Bay Eye AssociatesRecruiting
- Total Eye CareRecruiting
- Toyos ClinicRecruiting
- Advanced Laser Vision & Surgical InstituteRecruiting
- Lake Travis Eye & Laser Center/Revolution ResearchRecruiting
- PNV Clinical ResearchRecruiting
- The Eye Institute of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
5% Tavilermide ophthalmic solution
Vehicle ophthalmic solution