Confirmatory Study Nepafenac 0.3%

NCT01109173 | Completed Phase 3 Results

• 1 other identifier: C-09-055
• Study Type: interventional
• Target: 2,120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Cured at 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.

  Day 14

Secondary Outcomes (1)

• Percentage of Patients Pain-Free at Day 14

  Day 14

Study Arms (4)

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 dose was administered between 30-120 minutes prior to surgery.

Drug: Nepafenac Ophthalmic Suspension, 0.3%

NEVANAC

ACTIVE COMPARATOR

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 Vehicle 0.3%

PLACEBO COMPARATOR

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

NEVANAC Vehicle

PLACEBO COMPARATOR

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

Interventions

Nepafenac Ophthalmic Suspension, 0.3% DRUG

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.

Nepafenac 0.3%

Nepafenac Ophthalmic Suspension, 0.1% DRUG

Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days

Also known as: NEVANAC®

NEVANAC

Nepafenac Ophthalmic Suspension 0.3% Vehicle OTHER

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.

Nepafenac Vehicle 0.3%

NEVANAC Vehicle OTHER

Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

NEVANAC Vehicle

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

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

This study excluded patients who were under the age of 18, had uncontrolled glaucoma, were at risk of developing macular edema (eg, diabetic retinopathy), or 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

Study Officials

• Dana Sager, MS

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 21, 2010
• First Posted: April 23, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Last Updated: November 30, 2012
• Results First Posted: November 30, 2012

Record last verified: 2012-11

Locations

US (1)