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
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease Ocular Surface Disease||Drug: Brimonidine Tartrate Drug: Placebos||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
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.
|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|
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.
Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.
Other Name: Placebo (For Brimonidine Tartrate)
- 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
- Dry Eye (SANDE) questionnaire [ Time Frame: Between baseline and 12 weeks of treatment ]Change in Symptom Assessment scores
- 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
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
|Contact: Edward J Walters, MPHfirstname.lastname@example.org|
|Contact: Central Contact Email||OCU300email@example.com|
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, California|
|Los Angeles, California, United States, 90095|
|United States, Massachusetts|
|Study Research Center||Recruiting|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Durham, North Carolina, United States, 27708|
|United States, Ohio|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Study Director:||Edward J Walters, MPH||Ocugen, Inc.|