Nepafenac 0.3% Two Study

• ClinicalTrials.gov Identifier: NCT01318499
• Recruitment Status: Completed
• First Posted: March 18, 2011
• Results First Posted: December 17, 2012
• Last Update Posted: December 17, 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 Nepafenac Ophthalmic Suspension, 0.3% 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 Vehicle 0.3%	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1342 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% Compared to Nepafenac Ophthalmic Suspension 0.1% and Vehicle for Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery
• Study Start Date: March 2011
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 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 drop 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 drop was administered between 30-120 minutes prior to surgery.
Active Comparator: Nepafenac 0.1%; Nepafenac Ophthalmic Suspension, 0.1%, 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 drop was administered between 30-120 minutes prior to surgery.	Drug: Nepafenac Ophthalmic Suspension, 0.1%; Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.; Other Name: NEVANAC®
Placebo Comparator: Nepafenac Vehicle 0.3%; Nepafenac Vehicle 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 drop was administered between 30-120 minutes prior to surgery.	Other: Nepafenac Vehicle 0.3%; Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3% [ Time Frame: Day 14 postoperative ]
   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 aqueous cells and aqueous flare.

Secondary Outcome Measures :

1. Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1% [ Time Frame: Day 7 postoperative ]
   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 aqueous cells and aqueous flare.

Other Outcome Measures:

1. Cumulative Percentage of Patients Cured by Visit [ Time Frame: Day 1, Day 3, Day 7, 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 aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits.
2. Cumulative Percentage of Patients Pain Free by Visit [ Time Frame: Day 1, Day 3, Day 7, Day 14 ]
   Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits.

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

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01318499
• Other Study ID Numbers: C-11-003
• First Posted: March 18, 2011
• Results First Posted: December 17, 2012
• Last Update Posted: December 17, 2012
• Last Verified: December 2012

Keywords provided by Alcon Research:

cataract; inflammation; pain; inflammatory cells; aqueous flare

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