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

Ocugen

Status and phase

Completed

Phase 3

Conditions

Dry Eye

Treatments

Drug: Brimonidine Tartrate

Drug: Placebos

Study type

Interventional

Funder types

Industry

Identifiers

NCT03785340

OCU-310-301

Details and patient eligibility

About

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).

Full 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).

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease for ≥6 months
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
Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
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

Allergic to brimonidine or any similar products, or excipients of brimonidine
Use of contact lenses within 14 days prior to Screening visit or planned use during study
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, or others who may be considered vulnerable populations
Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
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
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