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

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MIM-D3 Ophthalmic Solution

Placebo Ophthalmic Solution

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ora, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

1% MIM-D3 Ophthalmic Solution

5% MIM-D3 Ophthalmic Solution

Placebo Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Corneal staining

Ocular surface damage

Secondary Outcome Measures

Tear film break-up time

Conjunctival redness

Tear osmolarity

Full Information

NCT ID

NCT01257607

First Posted

December 7, 2010

Last Updated

August 15, 2019

Sponsor

Mimetogen Pharmaceuticals USA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01257607

Brief Title

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

Official Title

A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 and 5% MIM-D3 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mimetogen Pharmaceuticals USA, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1% MIM-D3 Ophthalmic Solution

Arm Type

Experimental

Arm Title

5% MIM-D3 Ophthalmic Solution

Arm Type

Experimental

Arm Title

Placebo Ophthalmic Solution

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MIM-D3 Ophthalmic Solution

Intervention Description

28 Days, BID

Intervention Type

Drug

Intervention Name(s)

Placebo Ophthalmic Solution

Intervention Description

28 Days, BID

Primary Outcome Measure Information:

Title

Corneal staining

Description

Ocular surface damage

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Tear film break-up time

Time Frame

42 days

Title

Conjunctival redness

Time Frame

42 days

Title

Tear osmolarity

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail Torkildsen, MD

Organizational Affiliation

Andover Eye Associates

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Lonsdale, MD

Organizational Affiliation

Central Maine Eye Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ora, Inc.

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01830

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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