Dry Eye Disease, Dry Eye Syndromes, Kerato Conjunctivitis Sicca
Conditions
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.
Interventions
DRUG5% Tavilermide ophthalmic solution
Twice a day topicial dosing
OTHERVehicle ophthalmic solution
Twice a day topical dosing
Sponsors
Mimetogen Pharmaceuticals USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | Baseline to Day 85 | 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. |
| Change From Baseline in Eye Dryness Score as Measured by the VAS | Baseline to Day 85 | 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. |
Countries
United States
Outcome results
None listed