Clinical trial NCT03785340: Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Keywords: Dry Eye Disease
Lead sponsor: Ocugen
Sponsor class: INDUSTRY
First posted: 2018-12-24
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

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 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

Primary outcomes:
measure: Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
timeFrame: Baseline, 4 weeks (Day 28)
measure: Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
timeFrame: Baseline, 4 Weeks (Day 28)
Secondary outcomes:
measure: Change From Baseline to 2 Weeks (Day 14) in SANDE Score
timeFrame: Baseline, 2 weeks (Day 14)
measure: Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
timeFrame: Baseline, 2 Weeks (Day 14)
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Aesthetic Eye Care Institute/David Wirta, MD and Associates
state: California
city: Rancho Cordova
country: United States
facility: Martel Medical Eye Group
state: California
city: Pompano Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Mission
country: United States
facility: Heart of America Eye Care, P. A.
state: Kansas
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Cincinnati
country: United States
facility: Apex Eye- Kenwood
state: Ohio
city: Cincinnati
country: United States
facility: Apex Eye-Montgomery
state: Ohio
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Cranberry Township
country: United States
facility: Scott and Christie Eyecare Associates
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: Houston
country: United States
facility: Midtown Eye Physicans & Associates
state: Texas
city: Houston
country: United States
facility: Advanced Laser Vision & Surgical Institute
state: Texas
city: Lakeway
country: United States
facility: Revolution Research, Inc; Lake Travis Eye and Laser Center
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
References: