Confirmatory Study Nepafenac 0.3%

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Nepafenac Ophthalmic Suspension, 0.3%; Drug: Nepafenac Ophthalmic Suspension, 0.1%; Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle; Other: NEVANAC Vehicle

• Registration Number: NCT01109173
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2010-06
• Primary Completion: 2011-05
• Disposition First Submitted: 2012-07-17
• Disposition First Submitted QC: 2012-07-17
• Disposition First Posted: 2012-07-25
• Status Verified: 2012-11
• Results First Submitted: 2012-11-01
• Results First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Results First Posted: 2012-11-30
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nepafenac 0.3%	Nepafenac Ophthalmic Suspension, 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.
NEVANAC	Nepafenac Ophthalmic Suspension, 0.1%	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.
Nepafenac Vehicle 0.3%	Nepafenac Ophthalmic Suspension 0.3% Vehicle	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.
NEVANAC Vehicle	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Cured at Day 14	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Pain-Free at Day 14	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.

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States