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

NCT01257607 | Completed Phase 2 DMC

• 1 other identifier: MIM-724
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Corneal staining

  Ocular surface damage

  28 days

Secondary Outcomes (3)

• Tear film break-up time

  42 days

• Conjunctival redness

  42 days

• Tear osmolarity

  42 days

Study Arms (3)

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

MIM-D3 Ophthalmic Solution DRUG

28 Days, BID

1% MIM-D3 Ophthalmic Solution; 5% MIM-D3 Ophthalmic Solution

Placebo Ophthalmic Solution DRUG

28 Days, BID

Placebo Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mimetogen Pharmaceuticals USA, Inc.: lead

Study Sites (1)

Ora, Inc.

Andover, Massachusetts, 01830, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

• John Lonsdale, MD

  Central Maine Eye Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 9, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (1)