NCT01657266

Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification

Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract
• Phacoemulsification Cataract Surgery

Interventions

Type	Name	Description
DRUG	PRO-155	Pre-medication (before surgery) and maintenance treatment.
DRUG	Nevanac	Pre-medication (before surgery) and maintenance treatment.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2012-08-06
• Last updated: 2018-10-30
• Results posted: 2018-10-30

Locations

1 site across 1 country: Mexico