ISRCTN03110798已完成不适用
A Multicentre, Investigator-Masked, Parallel?Group, Randomized, Study of the Efficacy and Safety of Indomethacin 0.1% Eyedrops Compared with Ketorolac 0.5% Eyedrops in Ocular Inflammation After Cataract Surgery
Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)0 个研究点目标入组 120 人开始时间: 2010年3月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- 性别
- All
入选标准
- •Subjects must be of legal age (at least 18) and have full legal capacity to volunteer.
- •2. Subjects must read, understand, and sign the Institutional Review Board/Independent
- •Ethics Committee approved Informed Consent Form.
- •3. Subjects must be planning to undergo cataract surgery on one eye by
- •phacoemulsification with posterior chamber intraocular lens, using topical anaesthesia.
- •4. Subjects must have a preoperative flare = 15 ph/ms, measured with a laser flare meter
- •(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.
- •5. Subjects who are women of childbearing potential must have a negative urine
- •pregnancy test at baseline.
- •6. Subjects who are able and willing to comply with all treatment and follow-up
排除标准
- •1. Subjects who have an inflammatory and/or infectious pathology of the eye and its adnexa
- •2. Subjects who have a history of postoperative intraocular infection in the fellow eye
- •3. Subjects who have glaucoma in the study eye
- •4. Subjects who have post-traumatic cataract in the study eye
- •5. Subjects who have exfoliative syndrome
- •6. Subjects who have diabetes
- •7. Subjects who have an active peptic ulcer
- •8. Subjects who have severe hepatocellular impairment or severe renal impairment
- •9. Subjects who have a history of uveitis
- •10. Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents
- •11. Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study
- •12. Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration
- •13. Subjects with immunodepression
- •14. Subjects with a history of intolerance to the study drug or to any NSAI drug
- •15. Subjects who are monocular for any reason other than cataract
- •16. Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion
- •17. In the case of cataract surgery on the 2nd eye, if the subject was already included in the study for the 1st eye, the 2nd eye cannot be considered another study eye.
- •18. Subjects who have surgery planned to occur during the course of the study other than cataract surgery on the study eye or cataract surgery on the fellow eye. If cataract surgery is planned to occur for the fellow eye before Visit 5 (Day 30, ±3 days) is completed, the subject must be excluded.
- •19. Women who are pregnant or breastfeeding
- •20. Women who are sexually active and who do not fall into one of the following
- •categories:
- •20.1. Post menopausal
- •20.2. Surgically sterile
- •20.3. Using one of the following birth control methods throughout the duration of the study:
- •20.3.1. Intrauterine device (>14 days)
- •20.3.2. Barrier method (condom or diaphragm) with spermicide (>14 days)
- •20.3.3. Hormonal contraception (same dose and same formulation for at least six months)
- •Secondary criteria for exclusion from the efficacy analysis include perioperative complications (i.e., vitreous loss, complicated capsular rupture, and anterior chamber
- •intraocular lens) which will also be considered adverse events (AEs)
研究者
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