CTRI/2010/091/000280已完成3 期
A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Moxifloxacin 0.5% w/v + Bromfenac 0.09% w/v eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time)
- •2. Written informed consent to participate to the trial.
排除标准
- •1. Patients < 18 & > 60 years.
- •2. Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs;
- •3. Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded)
- •4. Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs;
- •5. Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery);
- •6. Patients who underwent preoperative and/or postoperative intravitreous injection of corticosteroids;
- •7. Patients who underwent sub-conjunctival injection
- •8. Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations;
- •9. Patients who underwent gas tamponade at the surgery;
- •10. Patients with endogenous uveitis;
- •11. Patients having corneal epithelial detachment or corneal ulcer in the target eye;
- •12. Patients who have allergy to corticosteroid drugs;
- •13. Patients who are required to wear contact lens during the study period;
- •14. Patients who are scheduled to undergo surgery of the opposite eye during the study period;
- •15. Patients who are pregnant or may be pregnant or lactating;
- •16. Patients who have participated in other clinical studies within 3 months.
研究者
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