EUCTR2010-019507-28-IT进行中（未招募）不适用
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery - Confirmatory Study Nepafenac 0.3%
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men or women of any race, 18 years or older who have cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens 2. Study eye of patients who in the opinion of the investigator will have improvement in best-corrected visual acuity after surgery 3. Patients should be able to understand and sign an informed consent that has been approved by an Institutional Review Board/Independent Ethics Committee. Note: Legally authorized representative of the patient can provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Planned multiple procedures during cataract/IOL implantation surgery (eg. trabeculectomy, corneal transplant). Note: A planned limbal relaxing incision may be performed for the correction of astigmatism. 2.Use of topical, topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit. 3.Use of topical, topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit. 4.Use of a topical ophthalmic prostaglandin in the operative eye (eg travoprost, latanoprost, bimatoprost, tafluprost). Patients with a previous history of topical ophthalmic prostaglandin use must discontinue at least 4 days prior to surgery and through study exit. 5.Any intraocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain greater than Grade 1 in the study eye that is present during the Baseline visit. 6.Previous ocular trauma to the operative eye (this includes cataract and previous intraocular surgery, where a wound is created to gain access to the anterior or posterior segments; this does not include previous laser therapy without use of an incision). 7.A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye. 8.Patients who in the opinion of the investigator are at increased risk of developing postoperative macular edema (eg. diabetic retinopathy) in the operative eye. 9.Currently diagnosed uncontrolled glaucoma in the operative eye. 10.Lens pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye. 11.Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye. 12.A visually nonfunctional fellow eye defined as a best-corrected visual acuity = 35 ETDRS letters (20/200 Snellen equivalent) or worse. 13.Participation in any other investigational drug or device study within 30 days before cataract surgery. 14.Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article 15. 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: a. they are breast-feeding; b. they have a positive urine pregnancy test at screening; c. they are not willing to undergo a urine pregnancy test upon entering or exiting the study; d. they intend to become pregnant during the duration of the study; or, e. they do not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal - oral, implantable, or injectable contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; IUD; or, surgical sterilization of partner).
研究者
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