Nepafenac Compared to Placebo for Ocular Pain and Inflammation

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Nepafenac Ophthalmic Suspension, 0.1%; Other: Nepafenac Vehicle Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426854

C-10-026

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups, including a placebo group

Nepafenac

Active Comparator group

Description:

Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.

Treatment:

Drug: Nepafenac Ophthalmic Suspension, 0.1%

Placebo

Placebo Comparator group

Description:

Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.

Treatment:

Other: Nepafenac Vehicle Ophthalmic Solution