Conditions: Cataract Phacoemulsification Cataract Surgery
Keywords: bromfenac nepafenac cataract phacoemulsification cataract surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.

Detailed description:
Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation.

This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.

Arms:
arm 1: Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye

Maintenance therapy: 1 drop 3 times a day for 30 days arm 2: Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension

Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye

Maintenance therapy: 1 drop 3 times a day for 30 days

Interventions: intervention 1: PRO-155 intervention 2: Nevanac
Intervention descriptions: intervention 1: Pre-medication (before surgery) and maintenance treatment. intervention 2: Pre-medication (before surgery) and maintenance treatment.

Protocol document: