Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

M

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

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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