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

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: MIM-D3 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution

• Registration Number: NCT01257607
• Lead Sponsor: Mimetogen Pharmaceuticals USA, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2019-08
• Disposition First Submitted: 2019-08-13
• Disposition First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-15
• Disposition First Posted: 2019-08-16
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% MIM-D3 Ophthalmic Solution	MIM-D3 Ophthalmic Solution	-
5% MIM-D3 Ophthalmic Solution	MIM-D3 Ophthalmic Solution	-
Placebo Ophthalmic Solution	Placebo Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Corneal staining	28 days	Ocular surface damage

Secondary Outcome Measures

Name	Time	Method
Conjunctival redness	42 days
Tear film break-up time	42 days
Tear osmolarity	42 days

Trial Locations

Locations (1)

Ora, Inc.; 🇺🇸 Andover, Massachusetts, United States