Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients with clinical cure at day 14. Clinical cure is<br /><br>defined as a score of 0 for both aqueous cells and flare.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The proportion of patients who are pain-free as assessed by the Investigator at<br /><br>day 14. Pain-free is defined as a score of 0 on the Investigator rating scale<br /><br>which ranges from 0 (none) to 5 (severe).</p><br>