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

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ClinicalTrials.gov Identifier: NCT03591874
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ocugen

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).

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Ocular Surface Disease Drug: Brimonidine Tartrate Drug: Placebos Phase 3

Detailed Description:

Ocular GVHD (oGVHD) is a common complication that occurs in 40-60% of patients who have undergone allogeneic bone marrow transplants. Driven by inflammation, oGVHD can result in damage to the ocular surface and tear-producing glands, which over time significantly diminishes quality of life and restricts daily activities due to visual impairment.

Early studies in animals and humans indicate that Brimonidine nano-emulsion, also known as OCU300, may relieve the signs and symptoms of oGVHD. These symptoms include blurry vision, foreign body sensation, burning sensation, severe light sensitivity, chronic conjunctivitis (pink or red eye), dry eyes and eye pain.

This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 15 centers. Upon meeting the eligibility criteria, enrolled subjects with a diagnosis of definite oGVHD will be randomly assigned in a 2:1 (test: control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.18% investigational product (test) or ophthalmic buffered saline (placebo).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCU-300
Brimonidine Tartrate Nanoemulsion Eye Drops 0.18% given 2 times a day for 12 weeks.
Drug: Brimonidine Tartrate
Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.
Other Name: OCU-300

Placebo Comparator: Placebos
Placebo - Ophthalmic buffered saline Eye Drops given 2 times a day for 12 weeks.
Drug: Placebos
Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.
Other Name: Placebo (For Brimonidine Tartrate)




Primary Outcome Measures :
  1. Validated Bulbar Redness (VBR) [ Time Frame: Between baseline and 12 weeks of treatment ]
    Ocular redness based on a 100-point scale measuring change in appearance.

  2. 10-point Visual Analog Scale (VAS) [ Time Frame: Between baseline and 12 weeks of treatment ]
    Measured change in Ocular discomfort intensity


Secondary Outcome Measures :
  1. Dry Eye (SANDE) questionnaire [ Time Frame: Between baseline and 12 weeks of treatment ]
    Change in Symptom Assessment scores


Other Outcome Measures:
  1. Validated Bulbar Redness (VBR) score [ Time Frame: At days 28 and 56 ]
    Change from baseline

  2. Ocular Discomfort Score [ Time Frame: At days 28 and 56 ]
    Change from baseline

  3. Ocular Surface Disease Index (OSDI) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline

  4. Corneal fluorescein staining (NEI score) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline

  5. Corneal Lissamine Green (LG) staining (NEI Scale) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline

  6. Conjunctival lissamine green (LG) staining (NEI Scale) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline

  7. Tear secretion as measured by Schirmer's test [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline

  8. Clinical global impression of change in signs and symptoms (Physician's rating) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline

  9. Subject global assessment of overall change (Subject's rating) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591874


Contacts
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Contact: Edward J Walters, MPH 484-237-3409 ed.walters@ocugen.com
Contact: Central Contact Email OCU300-301@ocugen.com

Locations
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United States, Arizona
Research Center Recruiting
Phoenix, Arizona, United States, 85054
United States, California
Research Center Recruiting
Los Angeles, California, United States, 90095
United States, Massachusetts
Study Research Center Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Research Center Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Research Center Recruiting
Durham, North Carolina, United States, 27708
United States, Ohio
Research Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Research Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Research Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Ocugen
Investigators
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Study Director: Edward J Walters, MPH Ocugen, Inc.

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Responsible Party: Ocugen
ClinicalTrials.gov Identifier: NCT03591874     History of Changes
Other Study ID Numbers: OCU-300-301
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is no current plan to share participant data with other researchers.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: A clinical Study Report will be submitted once the study data has been analyzed.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brimonidine Tartrate
Graft vs Host Disease
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs