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

Exclusion Criteria

• •1. Allergic to brimonidine or any similar products, or excipients of brimonidine
• •2. Use of contact lenses within 14 days prior to Screening visit or planned use during study
• •3. Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
• •4. Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
• •5. Intraocular pressure \<5 mmHg or \>22 mmHg in either eye
• •6. Active ocular infection or history of ocular herpetic keratitis
• •7. History of neurotrophic keratitis or ocular neuropathic pain
• •8. Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
• •9. Punctal occlusion within 3 months prior to Screening visit or during study
• •10. Corneal epithelial defect larger than 1 mm2 in either eye
• •11. Have active drug/alcohol dependence or abuse history
• •12. Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
• •13. Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
• •14. 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
• •15. In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
• •16. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol