NCT01387464已完成2 期
A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™ Once Daily (QD) Prior To Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Mean Aqueous Humor Bromfenac Concentration
研究概览
简要总结
The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
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 (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation
- •If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and 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 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)
排除标准
- •Use of any drug containing bromfenac within 2 weeks prior to surgery
- •Contact lens wear during the dosing period
- •Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications
- •Any serious complications with or macroscopic damage to the corneal epithelium
- •Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test
- •Currently suffer from alcohol and/or drug abuse
- •Prior participation in this study protocol
- •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
研究组 & 干预措施
ISV-303
Experimental
干预措施: ISV-303 (Drug)
Bromday™
Active Comparator
干预措施: Bromday™ (Drug)
结局指标
主要结局
Mean Aqueous Humor Bromfenac Concentration
时间窗: Approximately 3 hours post last dose
次要结局
未报告次要终点
研究者
相似试验
Unknown
不适用
Balneotherapy With Acquabios Thermal Water in Knee OsteoarthritisKnee OsteoarthritisNCT05352477University of Roma La Sapienza88
已完成
3 期
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT01911364Chiesi Farmaceutici S.p.A.3,686
已完成
3 期
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT01908140AstraZeneca933
已完成
3 期
Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)Asthma, Exercise-InducedNCT00090142Organon and Co62
已完成
3 期
Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)Asthma, Exercise-InducedNCT00092131Organon and Co51