Assessing the Safety and Efficacy of AVX-012 in Subjects With Mild-to-moderate Dry Eye Syndrome

Inclusion Criteria: * Male or female subjects of at least 18 years of age. * Diagnosis of dry eye (by a health care professional) for at least 3 months prior to screening visit. * Normal lid anatomy. * Intraocular pressure less than 22 mmHg (inclusive) in each eye. * Best-corrected visual acuity measured by ETDRS in each eye of 20/200 (logMAR 1.0) or better. * Schirmer I test score of ≥ 3 mm to ≤ 9 mm/ 5 min (with anesthesia). * SANDE symptom score of 50 or more. * Total ocular staining of minimum 1 in Oxford scale with fluorescein and/or green lissamine. * Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements. Exclusion Criteria: * History of other than dry eye, ocular surface of moderate to severe Meibomian gland disease (grades +++ to ++++ \[moderately to severely altered expressibility and secretion quality\]: moderate symptoms with mild to moderate corneal staining, mainly peripheral; or marked symptoms with marked corneal staining, central in addition), chronic, or acute ophthalmic disease in either eye, including glaucoma, macular degeneration, clinically significant cataract (primary or secondary). * Best-corrected visual acuity score of 55 letters read or lower in each eye as measured by ETDRS (letters read method). * Previous history of drug or any ingredient hypersensitivity. * Intraocular or strabismus surgery or glaucoma laser surgery within the previous 6 months. * History of refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, etc.). * Ocular trauma within the past 6 months. * Relevant ocular pathology judged by the investigator such as; eyelid anomalies, corneal disorders, metaplasia of the ocular surface, current filamentous keratitis, or corneal neovascularization. * Any history of herpes simplex or herpes zoster keratitis. * Ocular infection (bacterial, viral, or fungal) * Ocular medication of any kind, with the exception of artificial tears/gels/lubricants within the past 2 weeks of screening. * Cyclosporine treatment during the 6 months prior to enrolment. * Use of systemic medication that might cause dryness in the eye as a secondary effect (such as antihistaminics, hormone replacing therapies, etc.). * Use of contact lens * Use of additional artificial tears (other than study treatments) throughout the study, starting at screening visit. * Participation in an investigational drug or device trial within the 30 days previous to screening visit. * Any abnormality preventing reliable applanation tonometry of either eye. * Central corneal thickness greater than 600 μm by conventional pachymetry. * Signs of severe ocular surface diseases including corneal or conjunctival staining judged as severe by the investigator. * Clinically significant systemic disease including uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular, endocrine disorders, previous cerebrovascular accident with a significant residual motor or sensory defect, progressive neurologic disorders (Parkinsonism, dementias, multiple sclerosis, unstable acquired seizure disorders) which might interfere with the study as judged by the investigator. * Any systemic disease or medication that might course with known dryness in the eye. * Changes of systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening or anticipated during the study. * Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the investigational product or safe participation in this study. * Pregnant or breastfeeding females or those with a positive pregnancy test. * All females of childbearing potential must have a negative urine pregnancy test result at screening, and also agree to abstain from sexual intercourse with a male partner or agree to use a medically acceptable method of birth control (such as condom, diaphragm or cervical/vault cap with spermicide) until 28 days post-treatment. Males should also agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide until 28 days post-treatment.