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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

623

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2019

Shorter than P25 for phase_3

Geographic Reach

1 country

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

March 28, 2019

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

March 9, 2023

Completed

Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

April 19, 2019

Results QC Date

February 9, 2023

Last Update Submit

April 4, 2023

Conditions

Keratoconjunctivitis Sicca Dry Eye

Outcome Measures

Primary Outcomes (2)

Change From Baseline in Eye Dryness Score as Measured by the VAS
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.
Baseline to Day 85 in 5% Tavilermide versus Placebo
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
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. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Baseline to Day 85 in 5% Tavilermide versus Placebo

Study Arms (3)

1% Tavilermide ophthalmic solution

EXPERIMENTAL

Drug: Tavilermide ophthalmic solution

5% Tavilermide ophthalmic solution

EXPERIMENTAL

Drug: Tavilermide ophthalmic solution

Vehicle ophthalmic solution

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tavilermide ophthalmic solutionDRUG

BID topical dosing

1% Tavilermide ophthalmic solution5% Tavilermide ophthalmic solution

PlaceboOTHER

BID topical dosing

Vehicle ophthalmic solution

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.