Confirmatory Study Nepafenac 0.3%

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Other: NEVANAC Vehicle; Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle; Drug: Nepafenac Ophthalmic Suspension, 0.1%; Drug: Nepafenac Ophthalmic Suspension, 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01109173

C-09-055

Details and patient eligibility

About

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.

Enrollment: 2,120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,120 participants in 4 patient groups, including a placebo group

Nepafenac 0.3%

Experimental group

Description:

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.

Treatment:

Drug: Nepafenac Ophthalmic Suspension, 0.3%

NEVANAC

Active Comparator group

Description:

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.

Treatment:

Drug: Nepafenac Ophthalmic Suspension, 0.1%

Nepafenac Vehicle 0.3%

Placebo Comparator group

Description:

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.

Treatment:

Other: Nepafenac Ophthalmic Suspension 0.3% Vehicle

NEVANAC Vehicle

Placebo Comparator group

Description:

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.

Treatment:

Other: NEVANAC Vehicle