Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%
|ClinicalTrials.gov Identifier: NCT01310127|
Recruitment Status : Completed
First Posted : March 8, 2011
Results First Posted : September 26, 2013
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Pseudophakia||Drug: Bromfenac Drug: Nepafenac||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Treatment of Ocular Inflammation Associated With Cataract Surgery|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||May 2011|
Patients receiving Bromday self-administered one drop of bromfenac 0.09% daily as a topical ophthalmic drop three days prior to cataract surgery, on the day of cataract surgery and 21 days post operatively.
bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Other Name: Bromday (bromfenac ophthalmic solution) 0.9%
Active Comparator: Nevanac
Patients in this arm self-administered nepafenac topical ophthalmic drops three times daily beginning 3 days prior to cataract surgery, on the day of surgery and for 21 days postoperatively in addition to usual cataract procedure.
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
Other Name: Nevanac (nepafenac ophthamic suspension) 0.1%
- Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities [ Time Frame: Week 6 ]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.
- Summed Ocular Inflammation Score (SOIS) [ Time Frame: Week 6 ]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).
- OCT Retinal Thickness [ Time Frame: Week 6 ]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.
- Macular Volume [ Time Frame: 6 weeks ]Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310127
|Principal Investigator:||Melissa Cable, MD||Discover Vision Centers|