Confirmatory Study Nepafenac 0.3%

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: Nepafenac Ophthalmic Suspension, 0.3%
* Drug: Nepafenac Ophthalmic Suspension, 0.1%
* Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle
* Other: NEVANAC Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nepafenac 0.3%<br>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%<br>* 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.<br>|
| Active Comparator: NEVANAC<br>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%<br>* Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days<br>* Other names: NEVANAC®;|
| Placebo Comparator: Nepafenac Vehicle 0.3%<br>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<br>* 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.<br>|
| Placebo Comparator: NEVANAC Vehicle<br>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<br>* Nepafenac vehicle, one drop in affected eye three times daily, for 16 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |