Confirmatory Study Nepafenac 0.3% - Full Text View

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Nepafenac

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Percentage of Patients Cured at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
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:

Percentage of Patients Pain-Free at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
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.

Enrollment:	2120
Study Start Date:	June 2010
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109173

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

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01109173 History of Changes
Other Study ID Numbers:	C-09-055
Study First Received:	April 21, 2010
Results First Received:	November 1, 2012
Last Updated:	November 29, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Hungary: Ministry of Health, Social and Family Affairs Hungary: Institutional Ethics Committee Italy: Ministry of Health Italy: Ethics Committee Sweden: Institutional Review Board Sweden: Medical Products Agency Switzerland: Ethikkommission Switzerland: Federal Office of Public Health

Additional relevant MeSH terms:

Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013