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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Nepafenac; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Patients older than 18 years who require cataract surgery

• Both genders

• Provide informed consent

• Normal Laboratory results

Exclusion Criteria:

• Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery

• Patients with any trans-surgical complication

• Patients with a cataract >NC4, C4 or P4 classified with the system LOCS

• Patients with any active corneal pathology

• Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)

• Patients with IOP <5 or >21 mmHg

• Patients that have ocular pain, cellularity or flare at the moment of selection

• Patients with ocular exfoliation, trauma or any inflammatory disease

• Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus

• Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye

• Patients with history of hypersensitivity or contraindication for any drug used in the study

• Patients under anticoagulant treatment

• Contact lens users

• Pregnant patients, at risk of pregnancy or breastfeeding

• Patients without birth control treatment

• Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)

• Patients who had participated in any clinical trial in the last 90 days

• Legal or mentally disabled patients who could not give informed consent

• Patients who cannot comply with all study requirements