NCT01455233已完成4 期
Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery
Ophthalmology Consultants, Ltd.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- corneal health
研究概览
简要总结
The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.
详细描述
Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively.
Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (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
- •Men or woen of any race, 18 years or older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
- •Study eye of patients who, in the opinion of the investigator, will experience improvement in visual acuity following surgery
- •Patients who are able to understand and sign an informed consent form that has been approved by an IRB
排除标准
- •Planned multiple procedures during cataract/IOL implantation surgery. Note: A planned limbal relaxing incision may be performed for the correction of astigmatism
- •Use of topical ocular or systemic antibiotics within 14 days prior to surgery and through study exit
- •History of or Fuch's Corneal Endothelial Dystrophy
- •Any ocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain in the study eye that is present during the baseline visit.
- •Recent (within 6 months) ocular trama to the operative eye (this includes intraocular surgery)
- •A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye
- •Currently diagnosed uncontrolled glaucoma in the operative eye
- •Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye
- •A visually nonfunctional fellow eye defined as a best corrected visual acuity </= 35 ETDRS letters (20/200 Snellen equivalent) or worse
- •Participation in any other investigational drug or device study within 30 days before cataract surgery
- •Known or suspected allergy or hypersensitivity to any component of either test article
- •Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
- •they are breast feeding
- •they have a positive urine pregnancy test at screening
- •they are not willing to undergo a urine pregnancy test upon entering or exiting the study
- •they intend to become pregnant during the duration of the study; or,
- •they do not agree to use adequate birth control methods for the duration of the study
研究组 & 干预措施
besivance
Active Comparator
ocular antibiotic
干预措施: vigamox (Drug)
vigamox
Active Comparator
ocular antibiotic
干预措施: besivance (Drug)
结局指标
主要结局
corneal health
时间窗: through day 28 post op
Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28)
次要结局
- subject tolerance(day - 3 through day 28)
研究者
Joseph Gira, M.D.
Principal Investigator
Ophthalmology Consultants, Ltd.
研究点 (2)
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