A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease
Status: | Recruiting |
---|---|
Conditions: | Ocular, Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2016 |
End Date: | September 2016 |
Contact: | Garth Cumberlidge, PhD |
Email: | CEO@MIMETOGEN.COM |
Phone: | 617-395-8580 |
A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease
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 disease.
Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry
eye disease.
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) at Visit
1.
- Be 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 .
- 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 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
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