NCT01576952已完成3 期
A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 主要终点
- Ocular Inflammation
研究概览
简要总结
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
- •If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
- •Signature of the subject on the Informed Consent Form
- •Willing to avoid disallowed medication for the duration of the study.
- •Willing and able to follow all instructions and attend all study visits
- •Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
- •Additional inclusion criteria also apply
排除标准
- •Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
- •Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- •Currently suffer from alcohol and/or drug abuse
- •Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
- •A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
- •Additional exclusion criteria also apply
研究组 & 干预措施
ISV-303
Experimental
0.075% bromfenac in DuraSite vehicle dosed BID
干预措施: ISV-303 (Drug)
DuraSite Vehicle
Placebo Comparator
DuraSite Vehicle dosed BID
干预措施: DuraSite Vehicle (Other)
结局指标
主要结局
Ocular Inflammation
时间窗: 15 days
Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells, and no rescue medications.
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery SubjectsOcular InflammationNCT01808547Sun Pharmaceutical Industries Limited268
已完成
1 期
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery VolunteersOcular InflammationNCT01190878Sun Pharmaceutical Industries Limited169
已完成
2 期
Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic ConjunctivitisAllergic ConjunctivitisNCT02079649Alcon Research224
已完成
2 期
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)Wet Macular DegenerationNeovascular Age-related Macular DegenerationMacular DegenerationNCT05637255Sylentis, S.A.99
已完成
2 期
Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAGPrimary Open-Angle Glaucoma (POAG)Ocular Hypertension (OHT)NCT02829996Inotek Pharmaceuticals Corporation201