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

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

Study Overview

• Status: Completed
• Conditions: Cataract; Phacoemulsification Cataract Surgery
• Intervention / Treatment: Drug: PRO-155; Drug: Nevanac

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil de Guadalajara Fray Antonio Alcalde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelial Defects Detected With Fluorescein	The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated	measurements will be made at days 1, 5, 7 and 30
Epithelial Defects Detected With Green Lissamine	the percentage of patients presenting epithelial defects evaluated with green lysine will be reported	measurements will be made at days 1, 5, 7 and 30
Intraocular Pressure	Change from Baseline in the intraocular pressure after 30 days of treatment	day 30
Retinal Thickness	Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.	day 30 and 60

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.
• Investigators: Study Director: Leopoldo M. Baiza-Durán, MD, Laboratorios Sophia S.A de C.V.

Publications and helpful links

Helpful Links

• Palacio C, et al. Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population. Clinical Ophthalmology 2016;10:233-237

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: cataract; nepafenac; phacoemulsification cataract surgery; bromfenac
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Nepafenac
• Other Study ID Numbers: SOPH155-0412/II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The personal data were collected and analyzed according to confidentiality policy.