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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye

In brief

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).

Key facts

Study ID

NCT03785340

Run by

Ocugen

People needed

252

Starts

2018-12-03

Expected to finish

2019-02-25

Last updated by the study team

2022-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Aesthetic Eye Care Institute/David Wirta, MD and Associates — Newport Beach, California, United States
• Martel Medical Eye Group — Rancho Cordova, California, United States
• Rand Eye Institute — Pompano Beach, Florida, United States
• Chicago Cornea Consultants — Hoffman Estates, Illinois, United States
• Heart of America Eye Care, P. A. — Mission, Kansas, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Apex Eye- Kenwood — Cincinnati, Ohio, United States
• Apex Eye-Montgomery — Cincinnati, Ohio, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• Scott and Christie Eyecare Associates — Cranberry Township, Pennsylvania, United States
• Total Eye Care — Memphis, Tennessee, United States
• Toyos Clinic — Nashville, Tennessee, United States
• Midtown Eye Physicans & Associates — Houston, Texas, United States
• Advanced Laser Vision & Surgical Institute — Houston, Texas, United States
• Revolution Research, Inc; Lake Travis Eye and Laser Center — Lakeway, Texas, United States
• The Eye Institute of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.