The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Number of Participants With Anterior Chamber Cell Clearing
研究概览
简要总结
The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.
详细描述
A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)
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)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
- •Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
- •The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.
- •The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
- •The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
- •A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study.
- •The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.
排除标准
- •Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day
- •Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- •Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
- •Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
- •Patients with an allergy or hypersensitivity to dexamethasone.
- •Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
- •Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day
- •Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
- •Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
- •Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
研究组 & 干预措施
IBI-10090 low dose
IBI-10090 low dose
干预措施: IBI-10090 (Drug)
IBI-10090 med dose
IBI-10090 med dose
干预措施: IBI-10090 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Anterior Chamber Cell Clearing
时间窗: Day 8
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
次要结局
未报告次要终点