Dry Eye Disease Study With Brimonidine

• Status: Completed
• Trial end date: 2018-03-29
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ocugen
• Treatments: Brimonidine Tartrate; Carboxymethylcellulose Sodium; Ophthalmic Solutions

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

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

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