Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Mimetogen Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Dry Eye; Keratoconjunctivitis Sicca

Treatments: Other: Placebo; Drug: Tavilermide ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03925727

MIM-728

Details and patient eligibility

About

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.

Enrollment: 623 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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623 participants in 3 patient groups, including a placebo group

1% Tavilermide ophthalmic solution

Experimental group

Treatment:

Drug: Tavilermide ophthalmic solution

5% Tavilermide ophthalmic solution

Experimental group

Treatment:

Drug: Tavilermide ophthalmic solution

Vehicle ophthalmic solution

Placebo Comparator group

Treatment:

Other: Placebo