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

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