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Trial record 5 of 25 for:    "Lens Disease" | "Nepafenac"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01657266
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Cataract
Phacoemulsification Cataract Surgery
Interventions Drug: PRO-155
Drug: Nevanac
Enrollment 160
Recruitment Details 160 subjects were recruited, 12 of whom were excluded, 10 because they did not meet the selection criteria and 2 refused to participate. The remaining 148 were randomly assigned to one of the 2 study groups, 73 to bromfenac and 75 to napaphenac.
Pre-assignment Details  
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Period Title: Overall Study
Started 73 75
Completed 69 70
Not Completed 4 5
Reason Not Completed
Lost to Follow-up             2             2
Adverse Event             2             3
Arm/Group Title PRO-155 Nevanac Total
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Total of all reporting groups
Overall Number of Baseline Participants 69 70 139
Hide Baseline Analysis Population Description
Mexican patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 70 participants 139 participants
67.4  (11.1) 68.0  (9.5) 67.7  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Female
41
  59.4%
39
  55.7%
80
  57.6%
Male
28
  40.6%
31
  44.3%
59
  42.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Hispanic or Latino
69
 100.0%
70
 100.0%
139
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 69 participants 70 participants 139 participants
69 70 139
1.Primary Outcome
Title Percentage of Cellularity in Anterior Chamber
Hide Description Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Time Frame day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: Percentage of Cellularity
Day 1 64.2 64.3
Day 30 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-155
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Pearson´s Chi-square test
Comments [Not Specified]
2.Primary Outcome
Title Flare in Anterior Chamber
Hide Description Percentage of Participants with flare in anterior chamber after 30 days of treatment
Time Frame day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: Percentage of Participants with flare
Day 1 31.4 31.5
Day 30 0 0
3.Secondary Outcome
Title Percentage of Patients Without Ocular Pain
Hide Description percentage of patients without pain, would be measured using the Visual Analog Pain Scale
Time Frame day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: percentage of patients
Day 1 6.1 5.7
Day 30 1.5 1.6
4.Secondary Outcome
Title Mean Aqueous Concentration of Intervention Drug
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
We enrolled patients of both sexes (aged >18 years) with a diagnosis of cataract according to the Lens Opacities Classification System III ≤ NC4, C4 and, P4 in one eye were eligible for enrollment. Eligible patients must have had a best-corrected visual acuity of 6/60 (20/200) Snellen score.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
69 70
Mean (Standard Deviation)
Unit of Measure: ng/mL
207.5  (152.3) 314.4  (146.5)
5.Other Pre-specified Outcome
Title Epithelial Defects Detected With Fluorescein
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: percentage of patients with defects
Day 1 54.4 78.5
Day 7 32.5 64.4
Day 15 15.6 36.1
Day 30 6 8.5
6.Other Pre-specified Outcome
Title Epithelial Defects Detected With Green Lissamine
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: percentage of patients with defects
Day 1 62.5 86
Day 7 41.4 67.3
Day 15 21.6 57.4
Day 30 14.8 28.2
7.Other Pre-specified Outcome
Title Intraocular Pressure
Hide Description Change from Baseline in the intraocular pressure after 30 days of treatment
Time Frame day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 0 14.07  (1.82) 14.23  (1.90)
Day 1 14.66  (2.61) 15.83  (2.77)
Day 7 14.13  (1.97) 14.54  (1.85)
Day 15 13.81  (1.64) 13.91  (2.03)
Day 30 14.10  (1.78) 13.77  (1.97)
8.Other Pre-specified Outcome
Title Retinal Thickness
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

Overall Number of Participants Analyzed 69 70
Mean (Standard Deviation)
Unit of Measure: μm
field A1 day 0 247.24  (32.90) 250.87  (34.42)
field A1 day 30 252.06  (24.95) 264.08  (34.10)
field A1 day 60 254.06  (2.78) 260.13  (33.93)
Time Frame Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
Adverse Event Reporting Description

During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events:

  1. Serious or No serious
  2. Severity: mild, moderate, severe
  3. relation with study drug or not
 
Arm/Group Title PRO-155 Nevanac
Hide Arm/Group 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

PRO-155: Pre-medication (before surgery) and maintenance treatment.

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

Nevanac: Pre-medication (before surgery) and maintenance treatment.

All-Cause Mortality
PRO-155 Nevanac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PRO-155 Nevanac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/73 (0.00%)      2/75 (2.67%)    
Eye disorders     
Rhegmatogenous retinal detachment  [1]  0/73 (0.00%)  0 1/75 (1.33%)  1
central retinal artery occlusion  [2]  0/73 (0.00%)  0 1/75 (1.33%)  1
Indicates events were collected by systematic assessment
[1]
This serious adverse event occurred during the systematic assessment. The event was not related with the pharmacological intervention.
[2]
This serious adverse event occurred during systematic assessment. The adverse event was not related with the pharmacological intervention.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
PRO-155 Nevanac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/73 (6.85%)      2/75 (2.67%)    
Eye disorders     
Cystoid macular edema  [1]  1/73 (1.37%)  1 0/75 (0.00%)  0
Traumatic corneal desepithelization  [2]  1/73 (1.37%)  1 0/75 (0.00%)  0
Posterior Capsular Rupture  [3]  1/73 (1.37%)  1 0/75 (0.00%)  0
viral conjunctivitis  [4]  1/73 (1.37%)  1 0/75 (0.00%)  0
Inflammatory cells in the corneal endothelium  [5]  1/73 (1.37%)  1 0/75 (0.00%)  0
intraocular lens exchange  [6]  0/73 (0.00%)  0 1/75 (1.33%)  1
Vascular disorders     
fall from their own height  [7]  0/73 (0.00%)  0 1/75 (1.33%)  1
Indicates events were collected by systematic assessment
[1]
This moderate adverse event does not relationship with the study drug. The clinically significant cystoid macular edema occurs after cataract surgery.
[2]
This moderate event does not have relationship with the study drug. The patient presented an accidental ocular injure.
[3]
This mild adverse event does not relationship with the study drug. The posterior capsular rupture occurs after cataract surgery.
[4]
This severe adverse event does not have relationship with the study drug. This patient had hypothyroidism like concomitant disease, this clinical condition would be able to increase the risk to have an infectious disease.
[5]
This moderate adverse event does not have relationship with the study drug. The presence of inflammatory cells in the corneal endothelium is related to cataract surgery procedure.
[6]
This adverse event does not have relationship with the study drug. The reason of intraocular lens exchange was: error in the intraocular lens power calculation.
[7]
The mild adverse event does not have relationship with the study drug.
The study was performed according to the clinical protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

All the information is confidential and exclusive property of the sponsor. Information can be revealed only to my staff and regulatory agencies or ethics committee.

All the information from this protocol is confidential and exclusive property of the sponsor, it can not be revealed without written consent from the sponsor.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leopoldo M Baiza-Duran MD, Clinical trials Director
Organization: Laboratorios Sophia S.A. de C.V.
Phone: 52+ (33) 30 01 42 00
EMail: leopoldo.baiza@sophia.com.mx
Layout table for additonal information
Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01657266     History of Changes
Other Study ID Numbers: SOPH155-0412/II
First Submitted: July 19, 2012
First Posted: August 6, 2012
Results First Submitted: June 14, 2016
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018