A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Loteprednol etabonate 0.5 % + Gatifloxacin 0.3 % eye drops Vs. Gatifloxacin 0.3 % + Dexamethasone 0.1 % eye drops in patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Improvement in ocular inflammation and bacterial infection
研究概览
简要总结
A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Loteprednol etabonate + Gatifloxacin eye drops Vs.Gatifloxacin + Dexamethasone eye drops in patients with Inflammatory ocular conditions where bacterial ocular infection or a risk of ocular infection exist.The trial will be conducted on 100 patients and study will start on 21 oct 2010.
The primary outcome will be to measured inflammation by slit lamp biomicroscopic & following parameters will be assessed at Day 0, 3rd day, 5th day & 7th day.- Improvement in ocular inflammation and bacterial infection., Red or pink eyes, Eyelids sticking together especially in the morning,Itching,Excess tearing, White-yellow or cream colour thick sticky discharge, Watery discharge,Pain may be present,Virus infections and allergies often affect both eyes,Bleeding or hemorrhage can be seen as rupture of tiny blood vessels,Swelling of conjunctiva,Sensitivity to light,Swelling and redness for as long as 4 to 6 weeks after surgery,Decrease in visual acuity, sometimes caused by cystoid macular edema and secondary outcome will be Global assessment of efficacy and tolerability at 7th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- •2.Subjects who are candidate for routine, uncomplicated cataractsurgery.
- •3.Subjects who are not of childbearing potential.
- •Subjects must be willing and able to comply with all treatment and follow- up procedures.
排除标准
- •Patients < 18 & > 65 years.History of hypersensitivity to the study drug or similar class of drug.Pregnant or nursing femalesParticipation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
- •Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
- •Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
- •Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
结局指标
主要结局
Improvement in ocular inflammation and bacterial infection
时间窗: Day 0, day 3, day 5 & day 7.
次要结局
- Global assessment of efficacy and tolerability(7th day)