Dry Eye Disease Study With Brimonidine
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Brimonidine; Brimonidine Mono Therapy; sodium carboxymethylcellulose; Corticosteroid Eye Drop
Intervention description: Two products delivered in sequence twice daily.; Brimonidine given twice daily along with placebo drops; Placebo given twice daily.; Eye drop to be administered after Brimonidine in treatment arm 1
Intervention MeSH terms: Brimonidine Tartrate; Carboxymethylcellulose Sodium; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and
      without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 18 years or older.

          2. Sign and date informed consent form approved by the IRB

          3. History of Dry Eye Disease

          4. 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

          5. Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both
             Screening and Baseline (Day 1) visits

          6. Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye

          7. Women who satisfy one of the following:

               1. 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

               2. Are post-menopausal or have undergone a sterilization procedure

        Exclusion Criteria:

          1. Allergic to brimonidine, corticosteroids or any similar products, or excipients of
             brimonidine including benzalkonium chloride (BAK)

          2. Use of contact lenses

          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, institutionalized individuals, or
             others who may be considered vulnerable populations

         13. Received corticosteroid-containing eye drops within the past 7 days or systemic
             corticosteroids/immunosuppressives within the past 3 months

         14. Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic
             solution 5% (Xiidra™) within 30 days prior to Screening visit

         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