Phase 3
N=623
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Keratoconjunctivitis Sicca · Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT03925727 ↗Enrolled (actual)
623
Serious AEs
0.8%
Results posted
Mar 2023
Primary outcome: Primary: Change From Baseline in Eye Dryness Score as Measured by the VAS — -15.1; -20.6; -16.5 score on a scale — p=0.5533
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tavilermide ophthalmic solution (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mimetogen Pharmaceuticals USA, Inc.
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Eye Dryness Score as Measured by the VAS |
-15.1; -20.6; -16.5 | 0.5533 |
| PRIMARY Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale |
-2.6; -2.3; -2.1 | 0.0192 sig |
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.
Data sourced from ClinicalTrials.gov (NCT03925727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.