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Tohru Mizushima - One of the best experts on this subject based on the ideXlab platform.
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diclofenac protects cultured human corneal epithelial cells against hyperosmolarity and ameliorates corneal surface damage in a rat model of dry eye
Investigative Ophthalmology & Visual Science, 2014Co-Authors: Ryoichi Sawazaki, Tomoaki Ishihara, Shinya Usui, Erika Hayashi, Kayoko Tahara, Tatsuya Hoshino, Akihiro Higuchi, Shigeru Nakamura, Kazuo Tsubota, Tohru MizushimaAbstract:PURPOSE: Dry eye syndrome (DES) is characterized by an increase in tear osmolarity and induction of the expression and nuclear localization of an osmoprotective transcription factor (nuclear factor of activated T-cells 5 [NFAT5]) that plays an important role in providing protection against hyperosmotic tears. In this study, we screened medicines already in clinical use with a view of finding compounds that protect cultured human corneal epithelial cells against hyperosmolarity-induced cell damage. METHODS: Viable cell number was determined by the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) method and cellular NFAT5 level was measured by immunoblotting. The rat model for DES was developed by removal of the lacrimal glands, with an assessment of corneal surface damage based on levels of fluorescein staining and epithelial apoptosis. RESULTS: Some nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac sodium (diclofenac), were identified during the screening procedure. These NSAIDs were able to suppress hyperosmolarity-induced apoptosis and cell growth arrest. In contrast, other NSAIDs, including Bromfenac sodium (Bromfenac), did not exert such a protective action. Treatment of cells with diclofenac, but not Bromfenac, stimulated both the nuclear localization and expression of NFAT5 under hyperosmotic conditions. In the rat model for DES, topical administration of diclofenac (but not Bromfenac) to eyes reduced corneal surface damage without affecting the volume of tear fluid. CONCLUSIONS: Diclofenac appears to protect cells against hyperosmolarity-induced cell damage and NFAT5 would play an important role in this protective action. The findings reported here may also indicate that the topical administration of diclofenac to eyes may be therapeutically beneficial for DES patients.
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diclofenac protects cultured human corneal epithelial cells against hyperosmolarity and ameliorates corneal surface damage in a rat model of dry eye
Investigative Ophthalmology & Visual Science, 2014Co-Authors: Ryoichi Sawazaki, Tomoaki Ishihara, Shinya Usui, Erika Hayashi, Kayoko Tahara, Tatsuya Hoshino, Akihiro Higuchi, Shigeru Nakamura, Kazuo Tsubota, Tohru MizushimaAbstract:Purpose Dry eye syndrome (DES) is characterized by an increase in tear osmolarity and induction of the expression and nuclear localization of an osmoprotective transcription factor (nuclear factor of activated T-cells 5 [NFAT5]) that plays an important role in providing protection against hyperosmotic tears. In this study, we screened medicines already in clinical use with a view of finding compounds that protect cultured human corneal epithelial cells against hyperosmolarity-induced cell damage. Methods Viable cell number was determined by the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) method and cellular NFAT5 level was measured by immunoblotting. The rat model for DES was developed by removal of the lacrimal glands, with an assessment of corneal surface damage based on levels of fluorescein staining and epithelial apoptosis. Results Some nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac sodium (diclofenac), were identified during the screening procedure. These NSAIDs were able to suppress hyperosmolarity-induced apoptosis and cell growth arrest. In contrast, other NSAIDs, including Bromfenac sodium (Bromfenac), did not exert such a protective action. Treatment of cells with diclofenac, but not Bromfenac, stimulated both the nuclear localization and expression of NFAT5 under hyperosmotic conditions. In the rat model for DES, topical administration of diclofenac (but not Bromfenac) to eyes reduced corneal surface damage without affecting the volume of tear fluid. Conclusions Diclofenac appears to protect cells against hyperosmolarity-induced cell damage and NFAT5 would play an important role in this protective action. The findings reported here may also indicate that the topical administration of diclofenac to eyes may be therapeutically beneficial for DES patients.
Thomas R. Walters - One of the best experts on this subject based on the ideXlab platform.
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an ex vivo human aqueous humor concentration comparison of two commercial Bromfenac formulations
Clinical Ophthalmology, 2018Co-Authors: Thomas R. Walters, Robert Smythmedina, Paul CockrumAbstract:Purpose The purpose of this study was to quantify the concentration of Bromfenac in the aqueous humor utilizing high-performance liquid chromatography mass spectrometry between two commercial nonsteroidal anti-inflammatory drugs, using aqueous humor concentrations to characterize pharmacokinetic proportional differences between 0.075% Bromfenac ophthalmic solution in DuraSite (BromSite®) and 0.09% Bromfenac ophthalmic solution (Bromday®). Methods In this multicenter, randomized, double-masked, two-arm, parallel-group, comparative, Phase II clinical trial, subjects were assigned to receive Bromfenac in DuraSite or Bromfenac ophthalmic solution in a 1:1 ratio. One drop of the masked test article was instilled into the study eye once a day for 2 days prior to and 3 hours prior (last instillation) to the subject's cataract surgery. Aqueous humor samples were collected upon initial cataract incision for analysis of Bromfenac levels. The primary end point was aqueous humor concentration of Bromfenac at Day 3, at the initiation of cataract surgery. Aqueous humor samples were collected and analyzed for Bromfenac levels. Results A total of 60 subjects completed the study, 30 in each group. The mean Bromfenac aqueous humor concentration in subjects who received Bromfenac in DuraSite was more than twice (49.33±41.87 ng/mL, P=0.004) that of subjects who received Bromfenac ophthalmic solution (23.65±16.31 ng/mL) after three doses. Conclusion Mean Bromfenac aqueous humor concentration in subjects receiving the DuraSite-containing Bromfenac in DuraSite (0.075%) was significantly higher compared to subjects receiving Bromfenac ophthalmic solution (0.09%) after 3 days of dosing.
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a randomized double masked study to compare the ocular safety tolerability and efficacy of Bromfenac 0 075 compared with vehicle in cataract surgery subjects
Clinical Ophthalmology, 2016Co-Authors: Kamran Hosseini, Thomas R. Walters, Robert Davanzo, Richard L LindstromAbstract:PURPOSE The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of Bromfenac 0.075% in DuraSite® (Bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. METHODS A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to Bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. RESULTS At Day 15, proportionally more subjects in the Bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more Bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the Bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. CONCLUSION Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery.
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Bromfenac ophthalmic solution 0 07 dosed once daily for cataract surgery results of 2 randomized controlled trials
Ophthalmology, 2014Co-Authors: Thomas R. Walters, Damien F Goldberg, James H Peace, James A GowAbstract:Purpose To evaluate the efficacy and ocular safety of Bromfenac ophthalmic solution 0.07% (Prolensa) dosed once daily for the treatment of ocular inflammation and pain in subjects who underwent cataract surgery with posterior chamber intraocular lens implantation. Design Two phase 3, randomized, double-masked, placebo-controlled, multicenter clinical trials. Participants Four hundred forty subjects (440 study eyes: 222 in the Bromfenac group and 218 in the placebo group). Methods Two phase 3, prospective, randomized, double-masked, placebo-controlled clinical trials were conducted at 39 ophthalmology clinics in the United States. Subjects 18 years of age or older were randomized to receive either Bromfenac 0.07% or placebo dosed once daily beginning 1 day before cataract surgery, on the day of surgery, and continuing for 14 days after surgery (for a total of 16 days). Subjects were evaluated on days 1, 3, 8, 15, and 22 after surgery. The primary efficacy end point was cleared ocular inflammation, as measured by the summed ocular inflammation score of zero (anterior chamber cell count = 0 and absence of flare) by day 15. Secondary end points included cleared ocular inflammation at day 15 and the number of subjects who were pain free at day 1. The data from the 2 clinical trials were integrated for analyses. Main Outcome Measures Summed ocular inflammation score and ocular pain. Results A significantly higher proportion of subjects treated with Bromfenac 0.07% achieved complete clearance of ocular inflammation by day 15 and at day 15 compared with placebo ( P P P P = 0.0041). Conclusions Bromfenac ophthalmic solution 0.07% dosed once daily was clinically safe and effective compared with placebo for the treatment of ocular inflammation and pain in subjects who had undergone cataract surgery and may be a beneficial addition to the current standard of care, which commonly includes ophthalmic antibiotics and corticosteroids.
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in vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac amfenac ketorolac and Bromfenac
Journal of Cataract and Refractive Surgery, 2007Co-Authors: Thomas R. Walters, Priest Horace Ernest, Johnny L Gayton, Michael B Raizman, Robert LehmannAbstract:Purpose To evaluate the aqueous humor concentrations and cyclooxygenase (COX) inhibitory activities of nepafenac, amfenac, ketorolac, and Bromfenac after topical ocular administration of Nevanac (nepafenac 0.1%), Acular LS (ketorolac 0.4%), or Xibrom (Bromfenac 0.09%). Setting Five private ophthalmology practices throughout the United States. Methods Patients requiring cataract extraction were randomized to 1 of 3 treatment groups: Nevanac, Acular LS, or Xibrom. Patients were administered 1 drop of the test drug 30, 60, 120, 180, or 240 minutes before cataract surgery. At the time of paracentesis, an aqueous humor sample was collected and later analyzed for drug concentration. In addition, COX-1 (homeostatic) and COX-2 (inducible) inhibitory activities of nepafenac, amfenac, ketorolac, and Bromfenac were determined via the in vitro measurement of prostaglandin E2 (PGE2) inhibition. Results Seventy-five patients participated in the study. The prodrug nepafenac had the shortest time to peak concentration and the greatest peak aqueous humor concentration (Cmax). The Cmax of nepafenac was significantly higher than that of the other drugs (P Conclusion Nepafenac showed significantly greater ocular bioavailability and amfenac demonstrated greater potency at COX-2 inhibition than ketorolac or Bromfenac.
Ryoichi Sawazaki - One of the best experts on this subject based on the ideXlab platform.
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diclofenac protects cultured human corneal epithelial cells against hyperosmolarity and ameliorates corneal surface damage in a rat model of dry eye
Investigative Ophthalmology & Visual Science, 2014Co-Authors: Ryoichi Sawazaki, Tomoaki Ishihara, Shinya Usui, Erika Hayashi, Kayoko Tahara, Tatsuya Hoshino, Akihiro Higuchi, Shigeru Nakamura, Kazuo Tsubota, Tohru MizushimaAbstract:PURPOSE: Dry eye syndrome (DES) is characterized by an increase in tear osmolarity and induction of the expression and nuclear localization of an osmoprotective transcription factor (nuclear factor of activated T-cells 5 [NFAT5]) that plays an important role in providing protection against hyperosmotic tears. In this study, we screened medicines already in clinical use with a view of finding compounds that protect cultured human corneal epithelial cells against hyperosmolarity-induced cell damage. METHODS: Viable cell number was determined by the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) method and cellular NFAT5 level was measured by immunoblotting. The rat model for DES was developed by removal of the lacrimal glands, with an assessment of corneal surface damage based on levels of fluorescein staining and epithelial apoptosis. RESULTS: Some nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac sodium (diclofenac), were identified during the screening procedure. These NSAIDs were able to suppress hyperosmolarity-induced apoptosis and cell growth arrest. In contrast, other NSAIDs, including Bromfenac sodium (Bromfenac), did not exert such a protective action. Treatment of cells with diclofenac, but not Bromfenac, stimulated both the nuclear localization and expression of NFAT5 under hyperosmotic conditions. In the rat model for DES, topical administration of diclofenac (but not Bromfenac) to eyes reduced corneal surface damage without affecting the volume of tear fluid. CONCLUSIONS: Diclofenac appears to protect cells against hyperosmolarity-induced cell damage and NFAT5 would play an important role in this protective action. The findings reported here may also indicate that the topical administration of diclofenac to eyes may be therapeutically beneficial for DES patients.
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diclofenac protects cultured human corneal epithelial cells against hyperosmolarity and ameliorates corneal surface damage in a rat model of dry eye
Investigative Ophthalmology & Visual Science, 2014Co-Authors: Ryoichi Sawazaki, Tomoaki Ishihara, Shinya Usui, Erika Hayashi, Kayoko Tahara, Tatsuya Hoshino, Akihiro Higuchi, Shigeru Nakamura, Kazuo Tsubota, Tohru MizushimaAbstract:Purpose Dry eye syndrome (DES) is characterized by an increase in tear osmolarity and induction of the expression and nuclear localization of an osmoprotective transcription factor (nuclear factor of activated T-cells 5 [NFAT5]) that plays an important role in providing protection against hyperosmotic tears. In this study, we screened medicines already in clinical use with a view of finding compounds that protect cultured human corneal epithelial cells against hyperosmolarity-induced cell damage. Methods Viable cell number was determined by the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) method and cellular NFAT5 level was measured by immunoblotting. The rat model for DES was developed by removal of the lacrimal glands, with an assessment of corneal surface damage based on levels of fluorescein staining and epithelial apoptosis. Results Some nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac sodium (diclofenac), were identified during the screening procedure. These NSAIDs were able to suppress hyperosmolarity-induced apoptosis and cell growth arrest. In contrast, other NSAIDs, including Bromfenac sodium (Bromfenac), did not exert such a protective action. Treatment of cells with diclofenac, but not Bromfenac, stimulated both the nuclear localization and expression of NFAT5 under hyperosmotic conditions. In the rat model for DES, topical administration of diclofenac (but not Bromfenac) to eyes reduced corneal surface damage without affecting the volume of tear fluid. Conclusions Diclofenac appears to protect cells against hyperosmolarity-induced cell damage and NFAT5 would play an important role in this protective action. The findings reported here may also indicate that the topical administration of diclofenac to eyes may be therapeutically beneficial for DES patients.
David L Waterbury - One of the best experts on this subject based on the ideXlab platform.
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prostaglandin e2 inhibition of ketorolac 0 45 Bromfenac 0 09 and nepafenac 0 1 in patients undergoing phacoemulsification
Advances in Therapy, 2011Co-Authors: Frank A Bucci, David L WaterburyAbstract:We compared the prostaglandin E2 (PGE2) inhibition of three topical nonsteroidal antiinflammatory drugs (NSAIDs): ketorolac 0.45%, Bromfenac 0.09%, and nepafenac 0.1% at peak dosing levels in patients previously scheduled to undergo phacoemulsification. This was a single-center, double-masked observational study of 121 patients randomized to one of three NSAID treatment arms. Patients were instructed to take the NSAID per on-label dosing (twice daily [b.i.d.] for ketorolac 0.45% and Bromfenac 0.09%, three times a day [t.i.d.] for nepafenac 0.1%) for 1 day before surgery, and were to instill one drop the morning of surgery. Each patient received an additional four doses 1 hour prior to undergoing phacoemulsification. After completion of the paracentesis site with a super blade, aqueous humor (0.15 mL) was collected through the peripheral clear cornea with a 30 G needle attached to a tuberculin (TB) syringe. Aqueous humor samples were stored at −40°C prior to analysis, and diluted 1:10 with diluent. Assays were conducted on multiple plates in duplicate (seven standards per plate). The mean (±SD) PGE2 concentrations were 224.8±164.87 pg/mL for ketorolac 0.45% (n=42), 288.7±226.05 pg/mL for Bromfenac 0.09% (n=41), and 320.4±205.6 pg/mL for nepafenac 0.1% (n=38). The difference between ketorolac 0.45% and nepafenac 0.1% was statistically significant (P=0.025). The difference between Bromfenac 0.09% and nepafenac 0.1% was not significantly different (P=0.516). Ketorolac 0.45% achieved the greatest inhibition of PGE2 compared to nepafenac 0.1% and Bromfenac 0.09%. Ketorolac 0.45% may be more efficacious at controlling inflammation at the time of cataract surgery versus nepafenac 0.1% and Bromfenac 0.09%.
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aqueous prostaglandin e 2 of cataract patients at trough ketorolac and Bromfenac levels after 2 days dosing
Advances in Therapy, 2009Co-Authors: Frank A Bucci, David L WaterburyAbstract:Introduction Ketorolac 0.4% administered four times daily (q.i.d.) has long been used safely and effectively for the alleviation of ocular inflamation and pain and the prevention of intraoperative miosis in patients undergoing cataract surgery. Bromfenac ophthalmic solution 0.09% was recently developed as an ocular anti-inflammatory drug with a twice-daily (b.i.d.) dosing regimen. This study was designed to evaluate if b.i.d. dosing with Bromfenac 0.09%, in comparison with q.i.d. dosing with ketorolac 0.4%, provides adequate trough nonsteroidal anti-inflammatory drug levels that were effective enough to reduce aqueous prostaglandin (PG) E2 levels of patients after cataract surgery toward the end of its dosing cycle.
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comparison of ketorolac 0 4 and Bromfenac 0 09 at trough dosing aqueous drug absorption and prostaglandin e2 levels
Journal of Cataract and Refractive Surgery, 2008Co-Authors: Frank A Bucci, David L WaterburyAbstract:Purpose To compare aqueous drug concentrations and prostaglandin E 2 (PGE 2 ) levels in patients treated with ketorolac 0.4% and Bromfenac 0.09% at trough dosing. Setting Private practice, Wilkes-Barre, Pennsylvania, USA. Methods This single-center randomized investigator-masked clinical study comprised 56 patients having cataract surgery. Patients received 1 drop of ketorolac 0.4% or Bromfenac 0.09% 6 hours and 12 hours preoperatively consistent with on-label dosing schedules. Aqueous humor was collected at the start of surgery and analyzed for concentrations of ketorolac and Bromfenac using a reverse-phase high-performance liquid chromatography–mass spectroscopy system and for PGE 2 levels by competitive enzyme immunoassay. Results The mean aqueous PGE 2 level was 204.2 pg/mL ± 95.5 (SD) in patients treated with ketorolac 0.4% and 263.7 ± 90.0 pg/mL in patients treated with Bromfenac 0.09%, ( P = .020). The mean aqueous concentration of ketorolac and Bromfenac at trough dosing was 130.5 ± 37.8 ng/mL and 6.2 ± 3.1 ng/mL, respectively ( P = .004). Conclusions Higher aqueous levels and greater PGE 2 inhibition were observed in cataract surgery patients treated with ketorolac 0.4% than in patients treated with Bromfenac 0.09% at trough dosing. These findings suggest that ketorolac 0.4% administered 4 times a day may provide better control of prostaglandin-mediated inflammation than Bromfenac 0.09% administered twice a day.
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comparison of cyclooxygenase inhibitory activity and ocular anti inflammatory effects of ketorolac tromethamine and Bromfenac sodium
Current Medical Research and Opinion, 2006Co-Authors: David L Waterbury, David Silliman, Thierry JolasAbstract:ABSTRACTObjective: To compare the cyclooxygenase (COX) activity and anti-inflammatory effects of the nonsteroidal anti-inflammatory drugs (NSAIDs) ketorolac tromethamine (ketorolac) and Bromfenac sodium (Bromfenac).Methods: Cyclooxygenase activity and selectivity was determined in vitro by measuring prostaglandin E2 (PGE2) production following incubation of varying concentrations of NSAID with human recombinant COX‐1 or COX‐2 and arachidonic acid. Anti-inflammatory effects were evaluated in a rabbit model in which an ocular inflammatory response was induced by intravenous injection of 10 µg/kg lipopolysaccharide (LPS). In study animals, one eye was treated with 50 µL (+/–) ketorolac 0.4% (Acular LS) or Bromfenac 0.09% (Xibrom) and the other eye with 50 µL buffered saline. In control animals, both eyes were treated with vehicle. All animals were treated twice: 2 hours and 1 hour before LPS. ‡ Acular LS is a trade name of Allergan Inc, Irvine, CA, USA § Xibrom is a trade name of ISTA Pharmaceuticals, Irvine...
Melissa M. Toyos - One of the best experts on this subject based on the ideXlab platform.
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comparison of once daily Bromfenac 0 07 versus once daily nepafenac 0 3 in patients undergoing phacoemulsification
Ophthalmology and therapy, 2019Co-Authors: Melissa M. ToyosAbstract:AIM: Randomized pilot study comparing clinical outcomes with Bromfenac ophthalmic solution 0.07% versus nepafenac 0.3% ophthalmic suspension administered as identical dosing regimens in patients undergoing uncomplicated phacoemulsification with intraocular lens implantation. METHODS: Forty-nine subjects were treated with Bromfenac (n = 25) or nepafenac (n = 24) once daily starting 3 days before cataract surgery, continued on the day of surgery, and for 21 days following surgery, in addition to standard of care. Subjects were followed at 1 day and 7, 21, and 42 days postoperatively. Assessments included best-corrected visual acuity [Early Treatment Diabetic Retinopathy Study (ETDRS)], summed ocular inflammation score (SOIS; anterior chamber cells plus flare grading), macular volume and thickness (spectral domain optical coherence tomography), intraocular pressure, and adverse events. RESULTS: Treatment groups were similar at baseline. Outcomes for mean letters read (p = 0.20), mean change in macular volume (p = 0.98), and retinal thickness (p = 0.93) were not statistically different between the groups at day 42. Mean SOIS dropped markedly and similarly from post-surgical day 1 to day 7 in both treatment groups and was statistically equivalent to baseline in both groups by day 21. At day 42, 87% of subjects in the Bromfenac group and 82% of subjects in the nepafenac group demonstrated stable or improved visual acuity. The proportions of eyes with mean retinal thickness of 10 µm or less at days 7, 21, and 42 were similar for the Bromfenac (95.8%, 78.3%, 73.9%, respectively) and nepafenac (91.7%, 87.5%, 66.7%) groups (all p = NS, Bromfenac vs. nepafenac). CONCLUSION: Both Bromfenac 0.07% and nepafenac 0.3% produced positive and similar clinical outcomes with regard to ETDRS visual acuity post-cataract surgery when dosed using identical regimens. Increases in mean retinal thickness and mean macular volume were small and similar between treatments. TRIAL REGISTRATION NUMBER: NCT01847638. FUNDING: Bausch & Lomb Incorporated.
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comparison of once daily Bromfenac 0 07 versus once daily nepafenac 0 3 in patients undergoing phacoemulsification
Ophthalmology and therapy, 2019Co-Authors: Melissa M. ToyosAbstract:Randomized pilot study comparing clinical outcomes with Bromfenac ophthalmic solution 0.07% versus nepafenac 0.3% ophthalmic suspension administered as identical dosing regimens in patients undergoing uncomplicated phacoemulsification with intraocular lens implantation. Forty-nine subjects were treated with Bromfenac (n = 25) or nepafenac (n = 24) once daily starting 3 days before cataract surgery, continued on the day of surgery, and for 21 days following surgery, in addition to standard of care. Subjects were followed at 1 day and 7, 21, and 42 days postoperatively. Assessments included best-corrected visual acuity [Early Treatment Diabetic Retinopathy Study (ETDRS)], summed ocular inflammation score (SOIS; anterior chamber cells plus flare grading), macular volume and thickness (spectral domain optical coherence tomography), intraocular pressure, and adverse events. Treatment groups were similar at baseline. Outcomes for mean letters read (p = 0.20), mean change in macular volume (p = 0.98), and retinal thickness (p = 0.93) were not statistically different between the groups at day 42. Mean SOIS dropped markedly and similarly from post-surgical day 1 to day 7 in both treatment groups and was statistically equivalent to baseline in both groups by day 21. At day 42, 87% of subjects in the Bromfenac group and 82% of subjects in the nepafenac group demonstrated stable or improved visual acuity. The proportions of eyes with mean retinal thickness of 10 µm or less at days 7, 21, and 42 were similar for the Bromfenac (95.8%, 78.3%, 73.9%, respectively) and nepafenac (91.7%, 87.5%, 66.7%) groups (all p = NS, Bromfenac vs. nepafenac). Both Bromfenac 0.07% and nepafenac 0.3% produced positive and similar clinical outcomes with regard to ETDRS visual acuity post-cataract surgery when dosed using identical regimens. Increases in mean retinal thickness and mean macular volume were small and similar between treatments. NCT01847638. Bausch & Lomb Incorporated.
