A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 66
- 主要终点
- Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14
研究概览
简要总结
The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •At least 50 years of age
- •In good general health
排除标准
- •Any ocular surgery or use of topical antibiotics or antiseptics in either eye within the last 3 months
- •Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within 30 days of Baseline (or anticipated during the study)
- •Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during the study)
研究组 & 干预措施
Vigamox®
moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water
干预措施: moxifloxacin 0.5% HCI ophthalmic solution (Drug)
Zymar®
gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride
干预措施: gatifloxacin ophthalmic solution 0.3% (Drug)
结局指标
主要结局
Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14
时间窗: Day 14
Percentage of subjects with strain resistance as determined by Minimum Inhibitory Concentration (MIC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2.
次要结局
- Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14(Day 14)
- Minimum Inhibitory Concentration 50 (MIC50) at Day 14(Day 14)
- Minimum Inhibitory Concentration 90 (MIC90) at Day 14(Day 14)
- Minimum Inhibitory Concentration (MIC) Range at Day 14(Day 14)