Clinical trial NCT02634853: A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye
Official title: A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye
Lead sponsor: Mimetogen Pharmaceuticals USA, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-18
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: Day 57
measure: Ocular Discomfort
timeFrame: Day 57
Secondary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: Day 15
measure: Ocular Surface Disease Index
timeFrame: Day 57
measure: Ocular Dryness
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: MIM-727 Investigational Site
state: Kentucky
city: Nashville
country: United States
facility: MIM-727 Investigational Site
state: Tennessee
Study officials:
affiliation: Mimetogen Pharmaceuticals USA, Inc.
name: Garth Cumberlidge, PhD
role: STUDY_DIRECTOR
References: