Dry Eye
Conditions
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.
Interventions
28 Days, BID
DRUGPlacebo Ophthalmic Solution
28 Days, BID
Sponsors
Mimetogen Pharmaceuticals USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal staining | 28 days | Ocular surface damage |
Secondary
| Measure | Time frame |
|---|---|
| Tear film break-up time | 42 days |
| Conjunctival redness | 42 days |
| Tear osmolarity | 42 days |
Countries
United States
Outcome results
None listed