search
Back to results

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

Primary Purpose

Cataract, Phacoemulsification Cataract Surgery

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
PRO-155
Nevanac
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring bromfenac, nepafenac, cataract, phacoemulsification cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRO-155

Nevanac

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Patients Without Ocular Pain
percentage of patients without pain, would be measured using the Visual Analog Pain Scale
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.

Full Information

First Posted
July 19, 2012
Last Updated
February 8, 2018
Sponsor
Laboratorios Sophia S.A de C.V.
search

1. Study Identification

Unique Protocol Identification Number
NCT01657266
Brief Title
Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Phacoemulsification Cataract Surgery
Keywords
bromfenac, nepafenac, cataract, phacoemulsification cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRO-155
Arm Type
Experimental
Arm Description
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
Arm Title
Nevanac
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PRO-155
Intervention Description
Pre-medication (before surgery) and maintenance treatment.
Intervention Type
Drug
Intervention Name(s)
Nevanac
Intervention Description
Pre-medication (before surgery) and maintenance treatment.
Primary Outcome Measure Information:
Title
Percentage of Cellularity in Anterior Chamber
Description
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Time Frame
day 30
Title
Flare in Anterior Chamber
Description
Percentage of Participants with flare in anterior chamber after 30 days of treatment
Time Frame
day 30
Secondary Outcome Measure Information:
Title
Percentage of Patients Without Ocular Pain
Description
percentage of patients without pain, would be measured using the Visual Analog Pain Scale
Time Frame
day 30
Title
Mean Aqueous Concentration of Intervention Drug
Description
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.
Time Frame
before surgery
Other Pre-specified Outcome Measures:
Title
Epithelial Defects Detected With Fluorescein
Description
The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated
Time Frame
measurements will be made at days 1, 5, 7 and 30
Title
Epithelial Defects Detected With Green Lissamine
Description
the percentage of patients presenting epithelial defects evaluated with green lysine will be reported
Time Frame
measurements will be made at days 1, 5, 7 and 30
Title
Intraocular Pressure
Description
Change from Baseline in the intraocular pressure after 30 days of treatment
Time Frame
day 30
Title
Retinal Thickness
Description
Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.
Time Frame
day 30 and 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo M. Baiza-Durán, MD
Organizational Affiliation
Laboratorios Sophia S.A de C.V.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The personal data were collected and analyzed according to confidentiality policy.
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734805/pdf/opth-10-233.pdf
Description
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

Learn more about this trial

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

We'll reach out to this number within 24 hrs