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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MIM-D3 Ophthalmic Solution
Vehicle
Sponsored by
Mimetogen Pharmaceuticals USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

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

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

Sites / Locations

  • MIM-725 Investigational Site
  • MIM-725 Investigational Site
  • MIM-725 Investigational Site
  • MIM-725 Investigational Site
  • MIM-725 Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1% MIM-D3

Vehicle

Arm Description

1% MIM-D3 Ophthalmic Solution

Vehicle

Outcomes

Primary Outcome Measures

Corneal Fluorescein Staining
Ocular Dryness
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

Total Ocular Fluorescein Staining
Ocular Discomfort
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.

Full Information

First Posted
October 4, 2013
Last Updated
August 15, 2019
Sponsor
Mimetogen Pharmaceuticals USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01960010
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1% MIM-D3
Arm Type
Active Comparator
Arm Description
1% MIM-D3 Ophthalmic Solution
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
MIM-D3 Ophthalmic Solution
Other Intervention Name(s)
Tavilermide Ophthalmic Solution
Intervention Description
1% MIM-D3 dosed BID
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo Ophthalmic Solution
Intervention Description
Vehicle dosed BID
Primary Outcome Measure Information:
Title
Corneal Fluorescein Staining
Time Frame
Day 29
Title
Ocular Dryness
Description
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.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Total Ocular Fluorescein Staining
Time Frame
Day 29
Title
Ocular Discomfort
Description
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.
Time Frame
28 Days
Other Pre-specified Outcome Measures:
Title
Fluorescein staining (Ora CalibraTM Scale)
Description
Fluorescein Staining, (pre and post-CAESM; by individual region: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total), by both grade and clearance of staining;
Time Frame
Day 15, 29 and 57
Title
Lissamine green staining (Ora CalibraTM Scale,)
Description
Lissamine green staining (pre and post-CAESM; regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total)
Time Frame
Day 15, 29 and 57
Title
Subject diary individual symptoms
Time Frame
28-day and 56-day treatment periods
Title
Tear film break-up time
Description
Tear film break-up time (pre and post-CAESM);
Time Frame
Day 15, 29 and 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garth Cumberlidge, PhD
Organizational Affiliation
Mimetogen Pharmaceuticals USA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MIM-725 Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
MIM-725 Investigational Site
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
MIM-725 Investigational Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
MIM-725 Investigational Site
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
MIM-725 Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

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

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