Dry Eye Disease Study With Brimonidine

Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).

Inclusion criteria

• Aged 18 years or older.
• Sign and date informed consent form approved by the IRB
• History of Dry Eye Disease
• Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:

i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes

• Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
• Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye
• Women who satisfy one of the following:

• 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, OR
• Are post-menopausal or have undergone a sterilization procedure

Exclusion criteria

• Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)
• Use of contact lenses
• 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 <5 mmHg or >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, institutionalized individuals, or others who may be considered vulnerable populations
• Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months
• Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit
• 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