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

NCT03785340 | Completed Phase 3 Results FDA Drug

• 1 other identifier: OCU-310-301
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 16

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).

Conditions

Dry Eye

Keywords

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score

  The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

  Baseline, 4 weeks (Day 28)

• Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores

  Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.

  Baseline, 4 Weeks (Day 28)

Secondary Outcomes (2)

• Change From Baseline to 2 Weeks (Day 14) in SANDE Score

  Baseline, 2 weeks (Day 14)

• Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores

  Baseline, 2 Weeks (Day 14)

Study Arms (2)

OCU-310

EXPERIMENTAL

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

Drug: Brimonidine Tartrate

Placebos

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Brimonidine Tartrate DRUG

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

Also known as: OCU-310

OCU-310

Placebos DRUG

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

Also known as: Ophthalmic buffered saline solution

Placebos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• a. 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

Sponsors & Collaborators

• Ocugen: lead

Study Sites (16)

Aesthetic Eye Care Institute/David Wirta, MD and Associates

Newport Beach, California, 92663, United States

Location

Martel Medical Eye Group

Rancho Cordova, California, 95670, United States

Location

Rand Eye Institute

Pompano Beach, Florida, 33064, United States

Location

Chicago Cornea Consultants

Hoffman Estates, Illinois, 60169, United States

Location

Heart of America Eye Care, P. A.

Mission, Kansas, 66204, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Apex Eye- Kenwood

Cincinnati, Ohio, 45236, United States

Location

Apex Eye-Montgomery

Cincinnati, Ohio, 45242, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Scott and Christie Eyecare Associates

Cranberry Township, Pennsylvania, 16066, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Midtown Eye Physicans & Associates

Houston, Texas, 77004, United States

Location

Advanced Laser Vision & Surgical Institute

Houston, Texas, 77034, United States

Location

Revolution Research, Inc; Lake Travis Eye and Laser Center

Lakeway, Texas, 78734, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Vijay Tammara, VP, Strategic regulatory Operations
• Organization: Ocugen

Vijay.tammara@ocugen.com

484-328-4751

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: December 3, 2018
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: July 18, 2022
• Results First Posted: June 6, 2022

Record last verified: 2022-06

Locations

US (16)