Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)

Inclusion Criteria

• Aged 18 years or older.
• Sign and date informed consent form approved by the IRB
• History of Dry Eye Disease for ≥6 months
• Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):
• Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
• Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes
• Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
• Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
• Women who satisfy one of the following:

8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure

Exclusion Criteria

• Allergic to brimonidine or any similar products, or excipients of brimonidine
• Use of contact lenses within 14 days prior to Screening visit or planned use during study
• Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
• Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
• Intraocular pressure 22 mmHg in either eye
• Active ocular infection or history of ocular herpetic keratitis
• History of neurotrophic keratitis or ocular neuropathic pain
• Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
• Punctal occlusion within 3 months prior to Screening visit or during study
• Corneal epithelial defect larger than 1 mm2 in either eye
• Have active drug/alcohol dependence or abuse history
• Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
• Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
• Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
• In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
• Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol