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

NCT ID: NCT01257607

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1% MIM-D3 Ophthalmic Solution

Group Type: EXPERIMENTAL

MIM-D3 Ophthalmic Solution

Intervention Type: DRUG

28 Days, BID

5% MIM-D3 Ophthalmic Solution

Group Type: EXPERIMENTAL

MIM-D3 Ophthalmic Solution

Intervention Type: DRUG

28 Days, BID

Placebo Ophthalmic Solution

Group Type: PLACEBO_COMPARATOR

Placebo Ophthalmic Solution

Intervention Type: DRUG

28 Days, BID

Interventions

MIM-D3 Ophthalmic Solution

28 Days, BID

Intervention Type: DRUG

Placebo Ophthalmic Solution

28 Days, BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Be at least 18 years of age

2. Provide written informed consent

3. Have a reported history of dry eye

4. Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria

1. 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

2. Have any planned ocular and/or lid surgeries over the study period

3. 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

4. Have an uncontrolled systemic disease

5. Be a woman who is pregnant, nursing or planning a pregnancy

6. 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

7. Have a known allergy and/or sensitivity to the test article or its components

8. 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

9. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1

10. Be unable or unwilling to follow instructions, including participation in all study assessments and visits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mimetogen Pharmaceuticals USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Andover Eye Associates

John Lonsdale, MD

Role: PRINCIPAL_INVESTIGATOR

Central Maine Eye Care

Locations

Ora, Inc.

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

MIM-724

Identifier Type: -

Identifier Source: org_study_id