Safety and Efficacy Study of MIM-D3 Ophthalmic Solution f... | NCT01257607

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

NCT01257607

Sponsor

Mimetogen Pharmaceuticals USA, Inc.

Status

Completed

Last Update Posted

Aug 19, 2019Actual

Enrollment

150Actual

Phase

Phase 2

Conditions

Dry Eye

Interventions

MIM-D3 Ophthalmic Solution
Placebo Ophthalmic Solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Dec 7, 2010

First Submission Date that Met QC Criteria

Dec 8, 2010

First Posted Date

Dec 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 13, 2019

Certification/Extension First Submitted that Passed QC Review

Aug 13, 2019

Certification/Extension First Posted Date

Aug 16, 2019Actual

Last Update Submitted Date

Aug 15, 2019

Last Update Posted Date

Aug 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1% MIM-D3 Ophthalmic Solution	Experimental	Drug: MIM-D3 Ophthalmic Solution
5% MIM-D3 Ophthalmic Solution	Experimental	Drug: MIM-D3 Ophthalmic Solution
Placebo Ophthalmic Solution	Placebo Comparator	Drug: Placebo Ophthalmic Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MIM-D3 Ophthalmic Solution	Drug	28 Days, BID	1% MIM-D3 Ophthalmic Solution 5% MIM-D3 Ophthalmic Solution

Measure	Description	Time Frame
Corneal staining	Ocular surface damage	28 days

Measure	Description	Time Frame
Tear film break-up time		42 days
Conjunctival redness		42 days
Tear osmolarity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be at least 18 years of age
Provide 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gail Torkildsen, MD	Andover Eye Associates	Principal Investigator
John Lonsdale, MD	Central Maine Eye Care	Principal Investigator

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases