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

Phase 3

Completed

Conditions: Dry Eye Syndromes

Interventions: Drug: MIM-D3 Ophthalmic Solution
Drug: Vehicle

Registration Number: NCT01960010

Lead Sponsor: Mimetogen Pharmaceuticals USA, Inc.

Brief Summary: The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 403

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% MIM-D3	MIM-D3 Ophthalmic Solution	1% MIM-D3 Ophthalmic Solution
Vehicle	Vehicle	Vehicle

Primary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining	Day 29
Ocular Dryness	28 Days	Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.

Secondary Outcome Measures

Name	Time	Method
Total Ocular Fluorescein Staining	Day 29
Ocular Discomfort	28 Days	Patient-derived daily diary ocular discomfort symptoms for the 28 day time period will be averaged to obtain an ocular discomfort score for the entire 28-day period. Average ocular discomfort scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.