A Multicenter, Randomized, Dose-Ranging, Double-Masked, Placebo-Controlled Phase 2 Study Evaluating the Safety and Efficacy of RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 109
- 主要终点
- Absence of Anterior Chamber Cells at Day 15 (Visit 5)
研究概览
简要总结
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
详细描述
Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.
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
- Double (Participant, Investigator)
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
- •Be greater than or equal to 18 years of age of either sex or any race;
- •Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
- •Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
- •Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;
排除标准
- •Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
- •Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
- •Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface;
- •Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
- •Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;
- •Require the use of a contact lens or a collagen shield within 72 hours of investigational drug treatment or during the study period in the study eye; be unwilling to discontinue use of contact lenses during study period in the study eye;
- •Require use of non-diagnostic topical ophthalmic solutions (other than perioperative mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild blepharitis, or artificial tears for the management of dry eye) in the study eye for the duration of the study;
研究组 & 干预措施
Omaveloxolone Ophthalmic Suspension 1.0%
Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 1.0% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
干预措施: Omaveloxolone Ophthalmic Suspension 1.0% (Drug)
Omaveloxolone Ophthalmic Suspension 0.5%
Patients will receive a single drop of Omaveloxolone Ophthalmic suspension 0.5% instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
干预措施: Omaveloxolone Opthalmic Suspension 0.5% (Drug)
Placebo
Patients will receive a single drop of vehicle for Omaveloxolone Ophthalmic suspension was instilled into the study eye twice daily (approximately 12 hours apart) for 14 days, beginning 24 ± 6 hours after surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Absence of Anterior Chamber Cells at Day 15 (Visit 5)
时间窗: 15 days after the participant receives the first dose
Count of participants who had absence of anterior chamber cells at Day 15. White blood cells were counted. In a healthy eye, the anterior chamber should not have any blood cells present. "Yes" indicates an absence of anterior chamber cells. Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.
Absence of Ocular Pain at Day 4 (Visit 3)
时间窗: 4 days after the participant receives the first dose
Participants were asked to report their pain on Day 4 using the Numerical Pain Rating Scale (NPRS) for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from "0" representing "no pain" to "10" representing the "worst pain imaginable". Lower scores indicate less pain. Participants reporting '0' were recorded as "Yes" while patients reporting any other pain score were recorded as "No". Data for visits after a patient was discontinued for lack of efficacy were imputed as failures and missing data were imputed using last observation carried forward.
次要结局
未报告次要终点