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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257607
• Other study ID #: MIM-724
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2019
• Source: Mimetogen Pharmaceuticals USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• MIM-D3 Ophthalmic Solution
28 Days, BID
• Placebo Ophthalmic Solution
28 Days, BID

Locations

Country	Name	City	State
United States	Ora, Inc.	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mimetogen Pharmaceuticals USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal staining	Ocular surface damage	28 days
Secondary	Tear film break-up time		42 days
Secondary	Conjunctival redness		42 days
Secondary	Tear osmolarity		42 days