This trial is active, not recruiting.

Condition keratoconjunctivitis sicca
Treatments 1% tavilermide ophthalmic solution, placebo ophthalmic solution
Phase phase 3
Sponsor Mimetogen Pharmaceuticals USA, Inc.
Start date December 2015
End date September 2016
Trial size 400 participants
Trial identifier NCT02634853, MIM-727


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
1% Tavilermide Ophthalmic Solution
1% tavilermide ophthalmic solution
1% Tavilermide BID Dosing
(Placebo Comparator)
Placebo Ophthalmic Solution
placebo ophthalmic solution
Vehicle Ophthalmic Solution

Primary Outcomes

Corneal Fluorescein Staining
time frame: Day 57
Ocular Discomfort
time frame: Day 57

Secondary Outcomes

Corneal Fluorescein Staining
time frame: Day 15
Ocular Surface Disease Index
time frame: Day 57
Ocular Dryness
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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: 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

Additional Information

Official title A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mimetogen Pharmaceuticals USA, Inc..