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



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:December 3, 2018
End Date:February 28, 2019
Contact:Kevin Berth
Email:kevin.berth@ocugen.com
Phone:484-237-3398

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A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the
treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half
will receive ophthalmic buffered saline (placebo).

Dry eye disease (DED) is a common ocular disorder involving the aberrant production and
instability of tear film, which results in damage to the ocular surface and is correlated
with symptoms of ocular discomfort.

This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study
in the United States conducted at approximately 25 centers. Upon meeting the eligibility
criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to
receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or
ophthalmic buffered saline (placebo).

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 for ≥6 months

4. Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline
(Day 1):

1. Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and

2. Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes

5. Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at
Screening and Baseline (Day 1) visit

6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye

7. 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:

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
We found this trial at
16
sites
Cleveland, Ohio 44115
Phone: 216-937-2020
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Cincinnati, Ohio 45242
Phone: 513-561-5655
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Cincinnati, OH
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Cincinnati, Ohio 45236
Phone: 513-745-9787
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Cranberry Township, Pennsylvania 16066
Phone: 724-772-5420
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Cranberry Township, PA
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Hoffman Estates, Illinois
Phone: 847-748-3553
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Hoffman Estates, IL
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Houston, Texas 77034
Phone: 281-338-0425
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Houston, TX
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Houston, Texas 77004
Phone: 281-338-0425
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Houston, TX
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Lakeway, Texas 78734
Phone: 415-420-4650
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Lakeway, TX
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Memphis, Tennessee
Phone: 901-761-4620
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Memphis, TN
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Mission, Kansas 66204
Phone: 913-362-3210
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Mission, KS
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Nashville, Tennessee 37203
Phone: 615-327-4015
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Nashville, TN
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Newport Beach, California 92663
Phone: 949-650-1863
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Newport Beach, CA
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Pompano Beach, Florida 33064
Phone: 561-756-2835
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Pompano Beach, FL
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Rancho Cordova, California 95670
Phone: 916-631-7860
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Rancho Cordova, CA
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Saint Louis, Missouri 63131
Phone: 314-966-3377
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Saint Louis, MO
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Salt Lake City, Utah 84107
Phone: 801-263-5735
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Salt Lake City, UT
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