Confirmatory Study Nepafenac 0.3%

• ClinicalTrials.gov Identifier: NCT01109173
• Recruitment Status: Completed
• First Posted: April 23, 2010
• Results First Posted: November 30, 2012
• Last Update Posted: November 30, 2012
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

Condition or disease	Intervention/treatment	Phase
Cataract	Drug: Nepafenac Ophthalmic Suspension, 0.3%; Drug: Nepafenac Ophthalmic Suspension, 0.1%; Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle; Other: NEVANAC Vehicle	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery
• Study Start Date: June 2010
• Actual Primary Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nepafenac 0.3%; Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.	Drug: Nepafenac Ophthalmic Suspension, 0.3%; Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
Active Comparator: NEVANAC; Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.	Drug: Nepafenac Ophthalmic Suspension, 0.1%; Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days; Other Name: NEVANAC®
Placebo Comparator: Nepafenac Vehicle 0.3%; Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.	Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle; Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
Placebo Comparator: NEVANAC Vehicle; Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.	Other: NEVANAC Vehicle; Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

Outcome Measures

Primary Outcome Measures :

1. Percentage of Patients Cured at Day 14 [ Time Frame: Day 14 ]
   Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.

Secondary Outcome Measures :

1. Percentage of Patients Pain-Free at Day 14 [ Time Frame: Day 14 ]
   Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;
• Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
• Able to understand and sign an informed consent;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Use of 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;
• Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
• History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
• Diabetic retinopathy in the operative eye;
• Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

United States, Texas

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Dana Sager, MS; Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01109173
• Other Study ID Numbers: C-09-055
• First Posted: April 23, 2010
• Results First Posted: November 30, 2012
• Last Update Posted: November 30, 2012
• Last Verified: November 2012

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases; Nepafenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents