An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations
Thomas R Walters,1 Robert J Smyth-Medina,2 Paul C Cockrum31Keystone Research, Austin, TX, 2University of California, Los Angeles, CA, 3Health Kinetics, Fort Worth, TX, USAPurpose: The purpose of this study was to quantify the concentration of bromfenac in the aqueous humor utilizing high-performance...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-05-01
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| Series: | Clinical Ophthalmology |
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| Online Access: | https://www.dovepress.com/an-ex-vivo-human-aqueous-humor-concentration-comparison-of-two-commerc-peer-reviewed-article-OPTH |
| _version_ | 1818744358295306240 |
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| author | Walters TR Smyth-Medina RJ Cockrum PC |
| author_facet | Walters TR Smyth-Medina RJ Cockrum PC |
| author_sort | Walters TR |
| collection | DOAJ |
| description | Thomas R Walters,1 Robert J Smyth-Medina,2 Paul C Cockrum31Keystone Research, Austin, TX, 2University of California, Los Angeles, CA, 3Health Kinetics, Fort Worth, TX, USAPurpose: 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.Keywords: pharmacokinetics, PK, ocular, NSAID, aqueous humor |
| first_indexed | 2024-12-18T02:43:02Z |
| format | Article |
| id | doaj.art-4f1a6f621d244a82bd07e4d288573393 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-12-18T02:43:02Z |
| publishDate | 2018-05-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-4f1a6f621d244a82bd07e4d2885733932022-12-21T21:23:37ZengDove Medical PressClinical Ophthalmology1177-54832018-05-01Volume 1294394738401An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulationsWalters TRSmyth-Medina RJCockrum PCThomas R Walters,1 Robert J Smyth-Medina,2 Paul C Cockrum31Keystone Research, Austin, TX, 2University of California, Los Angeles, CA, 3Health Kinetics, Fort Worth, TX, USAPurpose: 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.Keywords: pharmacokinetics, PK, ocular, NSAID, aqueous humorhttps://www.dovepress.com/an-ex-vivo-human-aqueous-humor-concentration-comparison-of-two-commerc-peer-reviewed-article-OPTHPharmacokineticsPKocularNSAIDaqueous humor |
| spellingShingle | Walters TR Smyth-Medina RJ Cockrum PC An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations Clinical Ophthalmology Pharmacokinetics PK ocular NSAID aqueous humor |
| title | An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations |
| title_full | An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations |
| title_fullStr | An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations |
| title_full_unstemmed | An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations |
| title_short | An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations |
| title_sort | ex vivo human aqueous humor concentration comparison of two commercial bromfenac formulations |
| topic | Pharmacokinetics PK ocular NSAID aqueous humor |
| url | https://www.dovepress.com/an-ex-vivo-human-aqueous-humor-concentration-comparison-of-two-commerc-peer-reviewed-article-OPTH |
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