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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960010
• Other study ID #: MIM-725
• Status: Completed
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: August 2014

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• MIM-D3 Ophthalmic Solution
1% MIM-D3 dosed BID
• Vehicle
Vehicle dosed BID

Locations

Country	Name	City	State
United States	MIM-725 Investigational Site	Andover	Massachusetts
United States	MIM-725 Investigational Site	Lewiston	Maine
United States	MIM-725 Investigational Site	Memphis	Tennessee
United States	MIM-725 Investigational Site	Quincy	Massachusetts
United States	MIM-725 Investigational Site	Waterbury	Connecticut

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
Other	Fluorescein staining (Ora CalibraTM Scale)	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;	Day 15, 29 and 57
Other	Lissamine green staining (Ora CalibraTM Scale,)	Lissamine green staining (pre and post-CAESM; regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total)	Day 15, 29 and 57
Other	Subject diary individual symptoms		28-day and 56-day treatment periods
Other	Tear film break-up time	Tear film break-up time (pre and post-CAESM);	Day 15, 29 and 57
Primary	Corneal Fluorescein Staining		Day 29
Primary	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.	28 Days
Secondary	Total Ocular Fluorescein Staining		Day 29
Secondary	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.	28 Days