Nepafenac 0.3% Two Study

NCT01318499 | Completed Phase 2 Results

• 1 other identifier: C-11-003
• Study Type: interventional
• Target: 1,342
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

cataract; inflammation; pain; inflammatory cells; aqueous flare

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%

  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.

  Day 14 postoperative

Secondary Outcomes (1)

• Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%

  Day 7 postoperative

Other Outcomes (2)

• Cumulative Percentage of Patients Cured by Visit

  Day 1, Day 3, Day 7, Day 14

• Cumulative Percentage of Patients Pain Free by Visit

  Day 1, Day 3, Day 7, Day 14

Study Arms (3)

Nepafenac 0.3%

EXPERIMENTAL

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 0.1%

ACTIVE COMPARATOR

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 Vehicle 0.3%

PLACEBO COMPARATOR

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%

Interventions

Nepafenac Ophthalmic Suspension, 0.3% DRUG

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.

Nepafenac 0.3%

Nepafenac Ophthalmic Suspension, 0.1% DRUG

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.

Also known as: NEVANAC®

Nepafenac 0.1%

Nepafenac Vehicle 0.3% OTHER

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.

Nepafenac Vehicle 0.3%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract; Inflammation; Pain

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Study excluded patients who were under the age of 18, had uncontrolled glaucoma, were at risk of developing macular edema (diabetic retinopathy), and women of childbearing potential. Therefore, results may not be generalizable to these populations.

Results Point of Contact

• Title: Dana Sager, Clinical Manager Group Leader
• Organization: Alcon Research

dana.sager@alconlabs.com

1-817-551-8603

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 17, 2012
• Results First Posted: December 17, 2012

Record last verified: 2012-12

Locations

US (1)