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

• Sponsor: Mimetogen Pharmaceuticals USA, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01257607
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 5.9
• Patients Per Site Per Month: 25.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: MIM-D3 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1% MIM-D3 Ophthalmic Solution	Drug: MIM-D3 Ophthalmic Solution; 28 Days, BID
Experimental: 5% MIM-D3 Ophthalmic Solution	Drug: MIM-D3 Ophthalmic Solution; 28 Days, BID
Placebo Comparator: Placebo Ophthalmic Solution	Drug: Placebo Ophthalmic Solution; 28 Days, BID

Outcome Measures

Primary Outcome Measures

1. Corneal staining [28 days]

   Ocular surface damage

Secondary Outcome Measures

1. Tear film break-up time [42 days]

2. Conjunctival redness [42 days]

3. Tear osmolarity [42 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ora, Inc.	Andover	Massachusetts	United States	01830

Sponsors and Collaborators

• Mimetogen Pharmaceuticals USA, Inc.

Investigators

• Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates
• Principal Investigator: John Lonsdale, MD, Central Maine Eye Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mimetogen Pharmaceuticals USA, Inc.
• ClinicalTrials.gov Identifier: NCT01257607
• Other Study ID Numbers: MIM-724
• First Posted: Dec 9, 2010
• Last Update Posted: Aug 19, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Aug 19, 2019