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Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

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ClinicalTrials.gov Identifier: NCT01310127
Recruitment Status : Completed
First Posted : March 8, 2011
Results First Posted : September 26, 2013
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Melissa Toyos, Toyos Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Inflammation
Pseudophakia
Interventions Drug: Bromfenac
Drug: Nepafenac
Enrollment 23
Recruitment Details Clinical outcomes of bromfenac ophthalmic solution 0.09% QD and nepafenac 0.1% ophthalmic suspension TID post cataract surgery with posterior chamber intraocular lens implantation, specifically looking at any differences in Early Treatment Diabetic Retinopathy Study visual acuities, macular volume, and/or retinal thickness changes.
Pre-assignment Details Subjects were randomized to receive bromfenac(n=12) QD or nepafenac(n=11) TID. Dosing was 3 days before cataract surgery through day 21 postop. Subjects could not have used ocular/topical, systemic NSAIDs, gentamicin, or cyclosporine ophthalmic emulsion 7 days or prostaglandins 30 days prior to initial dosing of test article or during the study.
Arm/Group Title Bromday Nevanac
Hide Arm/Group Description Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
Period Title: Overall Study
Started 12 11
Completed 10 10
Not Completed 2 1
Reason Not Completed
Protocol Violation             1             1
advanced psc cataract outlier             1             0
Arm/Group Title Bromday Nevanac Total
Hide Arm/Group Description Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
1 nepafenac patient did not use test article prior to surgery. 1 bromday patient used nsaid during study. 1 bromday patient had advanced psc cataract.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  91.7%
10
  90.9%
21
  91.3%
>=65 years
1
   8.3%
1
   9.1%
2
   8.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 23 participants
70.1  (10.5) 69.7  (9.0) 69.9  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
5
  41.7%
6
  54.5%
11
  47.8%
Male
7
  58.3%
5
  45.5%
12
  52.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 11 participants 23 participants
12 11 23
1.Primary Outcome
Title Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities
Hide Description ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bromday Nevanac
Hide Arm/Group Description:
Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: letters
51.3  (6.818) 52  (6.750)
2.Primary Outcome
Title Summed Ocular Inflammation Score (SOIS)
Hide Description An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bromday Nevanac
Hide Arm/Group Description:
Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.15  (0.229) 0.2  (0.245)
3.Primary Outcome
Title OCT Retinal Thickness
Hide Description Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bromday Nevanac
Hide Arm/Group Description:
Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: micrometers cubed
230.7  (30.63) 223.8  (25.36)
4.Primary Outcome
Title Macular Volume
Hide Description Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bromday Nevanac
Hide Arm/Group Description:
Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mm cubed
0.1815  (0.49) 0.1765  (0.34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bromday Nevanac
Hide Arm/Group Description Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
All-Cause Mortality
Bromday Nevanac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bromday Nevanac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.05%
Bromday Nevanac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/11 (9.09%)    
Eye disorders     
recurrent symptomatic postoperative iritis * [1]  0/12 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
symptomatic recurrent postoperative iritis at final postoperative visit necessitating topical rescue medications
The major limitation in the study is that it was a small pilot study so that the direct correlations of the study variable could not be evaluated. There were ethnic differences in the groups that could also influence the data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Melissa Toyos, MD
Organization: Discover Vision Centers
Phone: 816-478-1230
Responsible Party: Melissa Toyos, Toyos Clinic
ClinicalTrials.gov Identifier: NCT01310127     History of Changes
Other Study ID Numbers: MAC-02-11
First Submitted: March 1, 2011
First Posted: March 8, 2011
Results First Submitted: April 25, 2013
Results First Posted: September 26, 2013
Last Update Posted: January 8, 2018