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CompletedNCT02634853Updated Aug 16, 2019

A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye

A Phase 3 interventional study of 1% Tavilermide Ophthalmic Solution and Placebo Ophthalmic Solution in Keratoconjunctivitis Sicca, sponsored by Mimetogen Pharmaceuticals USA, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-16.

Sponsored by Mimetogen Pharmaceuticals USA, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
429
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.

02

Conditions studied

  • Keratoconjunctivitis Sicca

Keywords

  • Dry Eye
03

In context

Keratoconjunctivitis Sicca

797 studies on the registry are indexed under Keratoconjunctivitis Sicca; 56 are open to participants now.

This study's enrollment of 429 is above the median of 73 across 674 interventional studies indexed under Keratoconjunctivitis Sicca.

Browse Keratoconjunctivitis Sicca studies →

Lead sponsor

Mimetogen Pharmaceuticals USA, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Be at least 18 years of age Provided written informed consent Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye

Exclusion criteria

Exclusion Criteria:

Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months Have any planned ocular and/or lid surgeries over the study period Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at 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; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study Have a known allergy and/or sensitivity to the test article or its components 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 of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
429 participants (actual)

Study arms

  • Active comparator
    Tavilermide Ophthalmic Solution

    1% Tavilermide Ophthalmic Solution

    Drug: 1% Tavilermide Ophthalmic Solution

  • Placebo comparator
    Vehicle Ophthalmic Solution

    Placebo Ophthalmic Solution

    Drug: Placebo Ophthalmic Solution

Interventions

06

What researchers measure

Primary outcomes

  1. Corneal Fluorescein Staining

    Time frame: Day 57

  2. Ocular Discomfort

    Time frame: Day 57

Secondary outcomes

  1. Corneal Fluorescein Staining

    Time frame: Day 15

  2. Ocular Surface Disease Index

    Time frame: Day 57

  3. Ocular Dryness

    Time frame: 8 weeks

07

Study locations

2 sites
  • MIM-727 Investigational Site
    Louisville, Kentucky, United States
  • MIM-727 Investigational Site
    Nashville, Tennessee, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02634853
Lead sponsor
Mimetogen Pharmaceuticals USA, Inc.
Responsible party
Sponsor
First posted
Dec 18, 2015
Start date
Dec 2015
Primary completion
Feb 2017
Completion
Mar 2017
Last update
Aug 16, 2019

Study contacts

Garth Cumberlidge, PhD
study director · Mimetogen Pharmaceuticals USA, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tavilermide

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