Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease (NCT03591874) | Clinical Trial Compass
TerminatedPhase 3
Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease
Stopped: Primary endpoint was not met.
United States59 participantsStarted 2018-12-23
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
Timeframe: Baseline, Day 84
2
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score