Nevanac 3-Month Safety Study With QID Dosing

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Other: Nepafenac ophthalmic suspension vehicle; Drug: Ketorolac Tromethamine ophthalmic solution 0.4%; Drug: Nepafenac ophthalmic solution 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332774

C-05-20

Details and patient eligibility

About

The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

Enrollment: 149 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Under 10
• 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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149 participants in 3 patient groups, including a placebo group

Nevanac

Experimental group

Treatment:

Drug: Nepafenac ophthalmic solution 0.1%

Acular

Active Comparator group

Treatment:

Drug: Ketorolac Tromethamine ophthalmic solution 0.4%

Vehicle

Placebo Comparator group

Treatment:

Other: Nepafenac ophthalmic suspension vehicle