Clinical trial NCT01426854: Nepafenac Compared to Placebo for Ocular Pain and Inflammation
Official title: Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery in Adult Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract Surgery
Anti-ocular Inflammation
Anti-ocular Pain
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular inflammation and pain associated with cataract surgery in Chinese subjects.


Eligibility criteria: Inclusion Criteria:

* Adult Chinese subjects, 18 years of age or older, of either sex who have a cataract, and are expected to undergo cataract extraction with the implantation of a posterior chamber intraocular lens;
* Study eye of subjects, who in the opinion of the Investigator, will have improvement in best-corrected visual acuity after surgery;
* Subjects should be able to understand and sign an informed consent that has been approved by an Independent Ethics Committee;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of topical ocular or systemic steroids within 14 days prior to surgery;
* Use of topical ocular or systemic non-steroidal anti-inflammatory drugs within 7 days of surgery, except an allowed daily dose of baby aspirin (81 mg);
* Subjects planning to have cataract surgery in their fellow, non-study eye prior to the 14 day postoperative study visit;
* Any intraocular inflammation or ocular pain greater than Grade 0 in the study eye that is present during the baseline slit-lamp exam;
* 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:

  * they are breast feeding;
  * they have a positive urine pregnancy test at baseline;
  * they are not willing to undergo a urine pregnancy test upon exiting the study;
  * they intend to become pregnant during the duration of the study; or,
  * they do not agree to using adequate birth control methods for the duration of the study.
* Any abnormality that prevents reliable tonometry;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Lens pseudoexfoliation syndrome with glaucoma or zonular compromise;
* Previous ocular trauma to the operative eye;
* A history of chronic or recurrent inflammatory eye disease;
* Ocular infection or ocular pain;
* Proliferative diabetic retinopathy;
* Uncontrolled diabetes mellitus;
* Congenital ocular anomaly;
* Iris atrophy in the operative eye;
* A nonfunctional fellow eye;
* Use of an investigational intraocular lens;
* Participation in any other clinical study within 30 days before surgery;
* Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory agents, or to any component of the study medication;
* Subjects with known bleeding tendencies, or who are receiving medications that may prolong bleeding time, may be enrolled at the physician's discretion; continuation of previous therapy for these subjects will be left to the judgment of the physician;
* The fellow eye of an individual currently or previously enrolled in the study;
* Subjects using a topical ophthalmic prostaglandin;
* Subjects, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Subjects With Clinical Cure at Day 14
timeFrame: Day 14 postoperative
Secondary outcomes:
measure: Proportion of Subjects Who Were Pain-Free at All Postoperative Visits
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Alcon (China) Ophthalmic Product Co., Ltd.
name: Mandy Ye, Director
role: STUDY_DIRECTOR
References: