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Trial record 6 of 155 for:    Brimonidine

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 : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ocugen

Tracking Information
First Submitted Date  ICMJE July 9, 2018
First Posted Date  ICMJE July 19, 2018
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE December 14, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • 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.
  • 10-point Visual Analog Scale (VAS) [ Time Frame: Between baseline and 12 weeks of treatment ]
    Measured change in Ocular discomfort intensity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03591874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
Dry Eye (SANDE) questionnaire [ Time Frame: Between baseline and 12 weeks of treatment ]
Change in Symptom Assessment scores
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 18, 2019)
  • Validated Bulbar Redness (VBR) score [ Time Frame: At days 28 and 56 ]
    Change from baseline
  • Ocular Discomfort Score [ Time Frame: At days 28 and 56 ]
    Change from baseline
  • Ocular Surface Disease Index (OSDI) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Corneal fluorescein staining (NEI score) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Corneal Lissamine Green (LG) staining (NEI Scale) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Conjunctival lissamine green (LG) staining (NEI Scale) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Tear secretion as measured by Schirmer's test [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Clinical global impression of change in signs and symptoms (Physician's rating) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Subject global assessment of overall change (Subject's rating) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
Original Other Pre-specified Outcome Measures
 (submitted: July 9, 2018)
  • Validated Bulbar Redness (VBR) score [ Time Frame: At days 28 and 56 ]
    Change from baseline
  • Ocular Discomfort Score [ Time Frame: At days 28 and 56 ]
    Change from baseline
  • Ocular Surface Disease Index (OSDI) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Corneal fluorescein staining (NEI score-all regions) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Conjunctival lissamine green (LG) staining (Oxford scale) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Tear secretion as measured by Schirmer's test [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Clinical global impression of change in signs and symptoms (Physician's rating) [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
  • Subject global assessment of overall change [ Time Frame: At 12 weeks (Day 84) ]
    Change from baseline
 
Descriptive Information
Brief Title  ICMJE Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Official Title  ICMJE 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
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).
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Graft Versus Host Disease
  • Ocular Surface Disease
  • oGVHD
  • Ocular Graft vs Host Disease
  • Brimonidine Tartrate
  • Lubricant Eye Drops
  • Ophthalmic Solutions
  • Graft vs Host Disease
Intervention  ICMJE
  • Drug: Brimonidine Tartrate
    Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.
    Other Name: OCU-300
  • Drug: Placebos
    Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.
    Other Name: Placebo (For Brimonidine Tartrate)
Study Arms  ICMJE
  • Experimental: OCU-300
    Brimonidine Tartrate Nanoemulsion Eye Drops 0.18% given 2 times a day for 12 weeks.
    Intervention: Drug: Brimonidine Tartrate
  • Placebo Comparator: Placebos
    Placebo - Ophthalmic buffered saline Eye Drops given 2 times a day for 12 weeks.
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edward J Walters, MPH 484-237-3409 ed.walters@ocugen.com
Contact: Central Contact Email OCU300-301@ocugen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03591874
Other Study ID Numbers  ICMJE OCU-300-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Ocugen
Study Sponsor  ICMJE Ocugen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edward J Walters, MPH Ocugen, Inc.
PRS Account Ocugen
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP