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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Ocugen
- 入组人数
- 59
- 试验地点
- 13
- 主要终点
- Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
OCU-300
Brimonidine Tartrate Nanoemulsion Eye Drops 0.18% given 2 times a day for 12 weeks.
干预措施: Brimonidine Tartrate (Drug)
Placebos
Placebo - Ophthalmic buffered saline Eye Drops given 2 times a day for 12 weeks.
干预措施: Placebos (Drug)
结局指标
主要结局
Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) Score
时间窗: Baseline, Day 84
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.
Change From Baseline to Day 84 in Ocular Discomfort Visual Analog Scale (VAS) Score
时间窗: Baseline, Day 84
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).
次要结局
- Change From Baseline to Day 84 in Symptom Assessment iN Dry Eye (SANDE) Questionnaire Scores(Baseline, Day 84)