NL-OMON34348撤回3 期
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%
Alcon Laboratories0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 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
- 年龄范围
- 18 至 99（—）
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
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
- •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
- •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
相似试验
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%The Prevention and Treatment of Ocular Inflammation and Pain after Cataract SurgeryEUCTR2010-019507-28-SEAlcon Research, Ltd.2,000
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%The prevention and treatment of ocular inflammation and pain after cataract surgery.MedDRA version: 9.1Level: LLTClassification code 10015943MedDRA version: 9.1Level: LLTClassification code 10015958EUCTR2010-019507-28-ITAlcon Research, Ltd.2,000
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%EUCTR2010-019507-28-HUAlcon Research, Ltd.2,000
已完成
2 期
Nepafenac 0.3% Two StudyCataractNCT01318499Alcon Research1,342
已完成
3 期
Confirmatory Study Nepafenac 0.3%CataractNCT01109173Alcon Research2,120