Clinical trial NCT01960010: A Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye
Official title: A Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 Ophthalmic Solution in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Mimetogen Pharmaceuticals USA, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 403
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 MIM-D3 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 29
measure: Ocular Dryness
timeFrame: 28 Days
Secondary outcomes:
measure: Total Ocular Fluorescein Staining
timeFrame: Day 29
measure: Ocular Discomfort
timeFrame: 28 Days
Other outcomes:
measure: Fluorescein staining (Ora CalibraTM Scale)
timeFrame: Day 15, 29 and 57
measure: Lissamine green staining (Ora CalibraTM Scale,)
timeFrame: Day 15, 29 and 57
measure: Subject diary individual symptoms
timeFrame: 28-day and 56-day treatment periods
measure: Tear film break-up time
timeFrame: Day 15, 29 and 57
Locations:
city: Waterbury
country: United States
facility: MIM-725 Investigational Site
state: Connecticut
city: Lewiston
country: United States
facility: MIM-725 Investigational Site
state: Maine
city: Andover
country: United States
facility: MIM-725 Investigational Site
state: Massachusetts
city: Quincy
country: United States
facility: MIM-725 Investigational Site
state: Massachusetts
city: Memphis
country: United States
facility: MIM-725 Investigational Site
state: Tennessee
Study officials:
affiliation: Mimetogen Pharmaceuticals USA, Inc.
name: Garth Cumberlidge, PhD
role: STUDY_DIRECTOR
References: