Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

NCT03591874 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: OCU-300-301
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 13

Brief Summary

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will receive Brimonidine and one third will receive ophthalmic buffered saline (placebo).

Conditions

Graft Versus Host Disease; Ocular Surface Disease; oGVHD; Ocular Graft vs Host Disease; Brimonidine Tartrate; Lubricant Eye Drops; Ophthalmic Solutions; Graft vs Host Disease

Keywords

ogvhd; ocular graft vs host; Ocular Surface Disease; Ocular Graft vs Host Disease; Brimonidine Tartrate; Lubricant Eye Drops; Ophthalmic Solutions; Graft vs Host Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score

  The VBR consists of a set of ten images illustrating different degrees of ocular redness, ranging from normal to severe, and each image is assigned a value from 10 (least redness) to 100 (most redness). The bulbar conjunctival injection of the participant's eye (nasal and temporal) was examined via slit-lamp examination and compared to the reference images in the VBR and graded accordingly.

  Baseline, Day 84

• Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score

  Participants were asked to rate their worst ocular pain/discomfort in the preceding 24 hours using a 10-point scale ranging from "None" (score=0) to "Unbearable/Excruciating" (score=10).

  Baseline, Day 84

Secondary Outcomes (1)

• Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores

  Baseline, Day 84

Study Arms (2)

OCU-300

EXPERIMENTAL

Brimonidine Tartrate Nanoemulsion Eye Drops 0.18% given 2 times a day for 12 weeks.

Drug: Brimonidine Tartrate

Placebos

PLACEBO COMPARATOR

Placebo - Ophthalmic buffered saline Eye Drops given 2 times a day for 12 weeks.

Drug: Placebos

Interventions

Brimonidine Tartrate DRUG

Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.

Also known as: OCU-300

OCU-300

Placebos DRUG

Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.

Also known as: Placebo (For Brimonidine Tartrate)

Placebos

Eligibility Criteria

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

You may qualify if:

• Men or women ≥ 18 years of age
• Diagnosis of definite oGVHD using the International Chronic Ocular GVHD Consensus Group Revised Diagnostic criteria in at least one eye.
• Ocular Discomfort score ≥ 3
• Validated Bulbar Redness score ≥ 40 in both eyes
• Subjects who are capable and willing to provide informed consent and follow study instructions
• Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
• Women who are not pregnant or lactating or post-menopausal or have undergone a sterilization procedure

You may not qualify if:

• Allergic to brimonidine or any similar products, or excipients of brimonidine
• Currently receiving any brimonidine or other treatment for glaucoma
• Receiving or have received any investigational drug or device within 30 days of screening
• Current use of contact lenses 14 days prior to screening
• Active ocular infection or ocular allergies
• Any history of eyelid surgery or ocular surgery within the past 3 months
• Corneal epithelial defect larger than 1 mm (squared) in either eye
• Received corticosteroid-containing eye drops within 14 days prior to screening or planned use during the study
• Any change in corticosteroid-containing eye drops, systemic corticosteroids/immunosuppressives, topical ocular antibiotics, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa®) or lifitegrast ophthalmic solution 5% (Xiidra®), or autologous serum tears within 30 days prior to screening or planned change during the study

Sponsors & Collaborators

• Ocugen: lead

Study Sites (13)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

University of Kansas Medical Center

Prairie Village, Kansas, 66208, United States

Location

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

OHSU Casey Eye Institute | Cornea Division

Portland, Oregon, 97239, United States

Location

University of Penn Scheie Eye Institute,

Philadelphia, Pennsylvania, 19104, United States

Location

Univeristy of Pittsburgh Medical Center Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Wisconsin Dept. of Ophthalmology and Visual Sciences

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Immune System 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
• Masking Details: All subjects, investigators, and study personnel involved in the conduct of the study, including data management and statistics, will be masked to treatment assignment except for a specified staff member from the designated packaging vendor who will do the package labeling. Unmasking will be permitted in a medical emergency that requires immediate knowledge of the subject's treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: December 23, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 6, 2022
• Results First Posted: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: A clinical Study Report will be submitted once the study data has been analyzed.

Locations

US (13)