Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataracts

Treatments: Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution; Other: Nepafenac vehicle eye drops; Drug: Nepafenac 1mg/ml eye drops, suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00405730

C-04-65

2005-002647-35

Details and patient eligibility

About

To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Under 18.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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227 participants in 3 patient groups, including a placebo group

Nepafenac

Experimental group

Description:

One drop in the study eye 3 times daily for 23 days

Treatment:

Drug: Nepafenac 1mg/ml eye drops, suspension

Ketorolac Trometamol

Active Comparator group

Description:

One drop in the study eye 3 times daily for 23 days

Treatment:

Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution

Nepafenac Vehicle

Placebo Comparator group

Description:

One drop in the study eye 3 times daily for 23 days

Treatment:

Other: Nepafenac vehicle eye drops