Confirmatory Study Nepafenac 0.3%

Cataract Clinical Trial

Official title:

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109173
• Other study ID #: C-09-055
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2010
• Last updated: November 29, 2012
• Start date: June 2010

Study information

• Verified date: November 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardHungary: Ministry of Health, Social and Family AffairsHungary: Institutional Ethics CommitteeItaly: Ministry of HealthItaly: Ethics CommitteeSweden: Institutional Review BoardSweden: Medical Products AgencySwitzerland: EthikkommissionSwitzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2120
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

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

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.
• NEVANAC Vehicle
Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Patients Pain-Free at 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.	Day 14	No