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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Cataract, Phacoemulsification Cataract Surgery

Intervention / Treatment
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* Drug: PRO-155
* Drug: Nevanac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO-155<br>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 | Drug: PRO-155<br>* Pre-medication (before surgery) and maintenance treatment.<br>|
| Active Comparator: Nevanac<br>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 | Drug: Nevanac<br>* Pre-medication (before surgery) and maintenance treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cellularity in Anterior Chamber | Change from Percentage of Cellularity in anterior chamber after 30 days of treatment. | day 30 | 
| Flare in Anterior Chamber | Percentage of Participants with flare in anterior chamber after 30 days of treatment | day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Without Ocular Pain | percentage of patients without pain, would be measured using the Visual Analog Pain Scale | day 30 | 
| Mean Aqueous Concentration of Intervention Drug | 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. | before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bromfenac, nepafenac, cataract, phacoemulsification cataract surgery