Clinical trial NCT01257607: Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Mimetogen Pharmaceuticals USA, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Corneal staining
timeFrame: 28 days
Secondary outcomes:
measure: Tear film break-up time
timeFrame: 42 days
measure: Conjunctival redness
timeFrame: 42 days
measure: Tear osmolarity
timeFrame: 42 days
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora, Inc.
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Maine Eye Care
name: John Lonsdale, MD
role: PRINCIPAL_INVESTIGATOR
References: