EUCTR2010-019507-28-HU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%
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 bestcorrected
- •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, 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)
- •In addition, an Alcon Medical Monitor may declare any patient ineligible for a valid medical reason.
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