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
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.
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 →Mimetogen Pharmaceuticals USA, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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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
1% Tavilermide Ophthalmic Solution
Drug: 1% Tavilermide Ophthalmic Solution
Placebo Ophthalmic Solution
Drug: Placebo Ophthalmic Solution
1% Tavilermide BID Dosing
Vehicle Ophthalmic Solution
Corneal Fluorescein Staining
Time frame: Day 57
Ocular Discomfort
Time frame: Day 57
Corneal Fluorescein Staining
Time frame: Day 15
Ocular Surface Disease Index
Time frame: Day 57
Ocular Dryness
Time frame: 8 weeks
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
Mimetogen Pharmaceuticals USA, Inc.