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

NCT ID: NCT03785340

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2019-02-25

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).

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OCU-310

Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks

Group Type: EXPERIMENTAL

Brimonidine Tartrate

Intervention Type: DRUG

Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.

Placebos

Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.

Interventions

Brimonidine Tartrate

Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.

Intervention Type: DRUG

Placebos

Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

OCU-310; Ophthalmic buffered saline solution

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocugen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

OCU-310-301

Identifier Type: -

Identifier Source: org_study_id