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

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Nevanac	Nevanac	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
PRO-155	PRO-155	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

Primary Outcome Measures

Name	Time	Method
Flare in Anterior Chamber	day 30	Percentage of Participants with flare in anterior chamber after 30 days of treatment
Percentage of Cellularity in Anterior Chamber	day 30	Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Without Ocular Pain	day 30	percentage of patients without pain, would be measured using the Visual Analog Pain Scale
Mean Aqueous Concentration of Intervention Drug	before surgery	a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification.