Page last updated: 2024-11-06

bromfenac

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Description

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that is a derivative of fenamic acid. It is used to treat pain and inflammation, particularly in the eye. It is available as an ophthalmic solution and is typically applied topically to the eye. The mechanism of action of bromfenac is thought to be similar to other NSAIDs. Bromfenac inhibits the production of prostaglandins, which are chemicals that cause pain and inflammation. While it's used for pain management, it's also been investigated for its potential to treat retinal diseases like diabetic macular edema. The research into bromfenac's effectiveness in treating eye conditions is ongoing, with studies exploring its ability to manage inflammation and improve vision.'

bromfenac: bromfenac sodium is the active cpd; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

bromfenac : Amfenac in which the the hydrogen at the 4 position of the benzoyl group is substituted by bromine. It is used for the management of ocular pain and treatment of postoperative inflammation in patients who have undergone cataract extraction. It was withdrawn from the US market in 1998, following concerns over off-label abuse and hepatic failure. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID60726
CHEMBL ID1077
CHEBI ID240107
SCHEMBL ID34411
MeSH IDM0150453

Synonyms (62)

Synonym
CHEMBL1077
ahr-10282
isv-303
bromfenac
bromfenac (inn)
91714-94-2
D07541
[2-amino-3-(4-bromo-benzoyl)-phenyl]-acetic acid
2-amino-3-(4-bromobenzoyl)benzeneacetic acid
DB00963
benzeneacetic acid, 2-amino-3-(4-bromobenzoyl)-
bromfenac [inn]
bromfenacum [latin]
bromfenaco [spanish]
{2-amino-3-[(4-bromophenyl)carbonyl]phenyl}acetic acid
bdbm50248104
2-[2-amino-3-(4-bromobenzoyl)phenyl]acetic acid
[2-amino-3-(4-bromobenzoyl)phenyl]acetic acid
bromfenacum
chebi:240107 ,
bromfenaco
2-[2-amino-3-(4-bromobenzoyl)phenyl]acetic acid;2-(2-amino-3-(4-bromobenzoyl)phenyl)acetic acid
A844048
2-(2-amino-3-(4-bromobenzoyl)phenyl)acetic acid
smr003500721
MLS004774052
AKOS015998697
864p0921dw ,
unii-864p0921dw
ahr 10282
bromfenac acid
gtpl7131
27R ,
bromfenac [who-dd]
bromfenac [vandf]
bromfenac [mi]
ZBPLOVFIXSTCRZ-UHFFFAOYSA-N
SCHEMBL34411
DTXSID7040655 ,
4MJQ
2-{2-amino-3-[(4-bromophenyl)carbonyl]phenyl}acetic acid
J-519935
mfcd00864341
GS-3830
sr-01000941476
SR-01000941476-2
benzeneacetic acid,2-amino-3-(4-bromobenzoyl)-
FT-0710423
Q2487682
BRD-K47679368-323-01-3
SB17362
HMS3741C05
A906783
VEA63855
CS-0013951
HY-B1888
(2-amino-3-(4-bromo-benzoyl)-phenyl)-acetic acid
s01bc11
(2-amino-3-(4-bromobenzoyl)phenyl)acetic acid
dtxcid5020655
bromfenacum (latin)
EN300-7368459

Research Excerpts

Overview

Bromfenac is a nonsteroidal anti-inflammatory drug that was approved in the United States in 1997. Bromfenac has a positive dose-response up to 25 mg for peak effects and 100 mg for total analgesic activity.

ExcerptReferenceRelevance
"Bromfenac is a nonsteroidal anti-inflammatory drug that was approved and subsequently withdrawn from the market because of reported cases of acute hepatotoxicity. "( Metabolite Profiling and Reaction Phenotyping for the
Carlson, TJ; Driscoll, JP; Shah, NR; Yadav, AS, 2020
)
2
"Bromfenac is a nonsteroidal anti-inflammatory drug that was approved in the United States in 1997. "( Role of Glucuronidation and P450 Oxidation in the Bioactivation of Bromfenac.
Driscoll, JP; Shah, NR; Yadav, AS, 2018
)
2.16
"Bromfenac is a safe and efficacious analgesic, with a threshold dose of 5 mg and a positive dose-response up to 25 mg for peak effects and 100 mg for total analgesic activity."( A dose-ranging study of bromfenac sodium in oral surgery pain.
Betts, NJ; Cooper, SA; Hersh, EV; Lamp, C; Levin, LM; Wajdula, J; Wedell, D, 1998
)
2.05
"Bromfenac is a nonsteroidal anti-inflammatory drug whose peak plasma concentration is reached 0.5 hours after oral administration. "( Clinical pharmacokinetics and pharmacodynamics of bromfenac.
Davies, NM; Skjodt, NM, 1999
)
2

Effects

ExcerptReferenceRelevance
"Bromfenac has shown promise in inhibiting the COX-2 enzymatic pathway that partially causes the inflammatory cascade which contributes to the precipitation of ME."( Intravitreal bromfenac liposomal suspension (100 μg / 0.1 ml). A safety study in rabbit eyes.
García-Arzate, D; García-Sánchez, GA; García-Santisteban, R; Gonzalez-Salinas, R; Hernández-Piñamora, E; Linares-Alba, MA; Morales-Cantón, V; Quiroz-Mercado, H; Rodríguez-Reyes, AA; Sánchez-Santos, I; Tirado-González, V, 2020
)
1.65

Actions

ExcerptReferenceRelevance
"Bromfenac can cause idiosyncratic hepatic toxicity and has been withdrawn by its manufacturer pending further investigation of these case reports."( Clinical pharmacokinetics and pharmacodynamics of bromfenac.
Davies, NM; Skjodt, NM, 1999
)
1.28

Treatment

Most bromfenac-treated patients (71%) returned to normal activities within 2 days of starting treatment. Treatment with brom Fenac ophthalmic solution did not prevent either complication.

ExcerptReferenceRelevance
"bromfenac-treated eyes at 4 weeks, and in bromfenac- vs."( Efficacy of COX-2 inhibitors in controlling inflammation and capsular opacification after phacoemulsification cataract removal.
Brookshire, HL; English, RV; Gift, BW; Gilger, BC; Nadelstein, B; Weigt, AK, 2015
)
1.14
"Most bromfenac-treated patients (71%) returned to normal activities within 2 days of starting treatment with bromfenac, compared with 0% of controls (P=0.018)."( Efficacy and safety of bromfenac for the treatment of corneal ulcer pain.
Schechter, BA; Trattler, W, 2010
)
1.13
"Treatment with bromfenac ophthalmic solution did not prevent either complication."( Efficacy of ophthalmic nonsteroidal antiinflammatory drugs in suppressing anterior capsule contraction and secondary posterior capsule opacification.
Aose, M; Gotoh, N; Matsui, E; Matsushima, H; Mukai, K; Nagata, M; Satoshi, W; Senoo, T; Wataru, T, 2009
)
0.69

Toxicity

Sodium bromfenac eye drops were effective in treating pain associated with infectious keratitis and did not delay corneal epithelialization. The incidence of adverse events reported in the brom Fenac 0.0 eye drops was low.

ExcerptReferenceRelevance
"The removal of 5 pharmaceuticals from the market in a 12-month period because of unexpected adverse events raised concerns about the adequacy of the drug review process at the US Food and Drug Administration (FDA)."( The safety of newly approved medicines: do recent market removals mean there is a problem?
Friedman, MA; Hass, AE; Lumpkin, MM; Shuren, JE; Thompson, LJ; Woodcock, J, 1999
)
0.3
" Since that review, some new knowledge allows us to better predict that some structural moieties are more likely than others to form drug reactive metabolites that may be involved in causing toxic effects in humans."( Structure toxicity relationships--how useful are they in predicting toxicities of new drugs?
Nelson, SD, 2001
)
0.31
" No clinically significant treatment-related systemic adverse effects or changes in liver chemistries were observed."( The systemic safety of bromfenac ophthalmic solution 0.09%.
Donnenfeld, ED; Gow, JA; Grillone, LR; Shiffman, ML; Stewart, RH, 2007
)
0.65
"09% demonstrated neither treatment-related systemic adverse events nor evidence of hepatic toxicity."( The systemic safety of bromfenac ophthalmic solution 0.09%.
Donnenfeld, ED; Gow, JA; Grillone, LR; Shiffman, ML; Stewart, RH, 2007
)
0.65
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" The best corrected visual acuity, location, size, and density of corneal infiltrates, the size and presence of a corneal epithelial defect, subjective eye pain (scale of 0-4) and time to pain resolution, the ability to conduct daily activities, and adverse events were recorded at each follow-up visit."( Efficacy and safety of bromfenac for the treatment of corneal ulcer pain.
Schechter, BA; Trattler, W, 2010
)
0.67
" No adverse events were recorded."( Efficacy and safety of bromfenac for the treatment of corneal ulcer pain.
Schechter, BA; Trattler, W, 2010
)
0.67
"Bromfenac was effective in treating pain associated with infectious keratitis and did not delay corneal epithelialization nor cause any corneal adverse events in this group of 25 eyes."( Efficacy and safety of bromfenac for the treatment of corneal ulcer pain.
Schechter, BA; Trattler, W, 2010
)
2.11
"09% dosed once daily was clinically safe and effective for reducing and treating ocular inflammation and pain associated with cataract surgery."( Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain.
Chandler, SP; Gayton, JL; Gow, JA; Henderson, BA; Klier, SM; McNamara, TR, 2011
)
0.68
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
"1 ml) is not toxic and has been proven safe to use in an animal model."( Intravitreal bromfenac liposomal suspension (100 μg / 0.1 ml). A safety study in rabbit eyes.
García-Arzate, D; García-Sánchez, GA; García-Santisteban, R; Gonzalez-Salinas, R; Hernández-Piñamora, E; Linares-Alba, MA; Morales-Cantón, V; Quiroz-Mercado, H; Rodríguez-Reyes, AA; Sánchez-Santos, I; Tirado-González, V, 2020
)
0.93
" Cataract surgery is often accompanied by severe inflammation, and glucocorticoid therapy has many adverse reactions and side effects."( Efficacy and safety of sodium bromfenac eye drops in the treatment of postoperative inflammation in cataract surgery: A protocol for systematic review and meta-analysis.
Cai, M; Cao, Y; Chen, X; Huang, W; Wang, C, 2020
)
0.85
"In this study, the efficacy and safety of sodium bromfenac eye drops in the treatment of postoperative inflammation of cataract surgery were evaluated by the effective rate, symptom score, adverse reactions, incidence, recurrence rate, etc."( Efficacy and safety of sodium bromfenac eye drops in the treatment of postoperative inflammation in cataract surgery: A protocol for systematic review and meta-analysis.
Cai, M; Cao, Y; Chen, X; Huang, W; Wang, C, 2020
)
1.1

Pharmacokinetics

The pharmacokinetic profile of bromfenac (2-amino-3-(4-bromobenzoyl) benzeneacetic acid, CAS91714-93-1) has been investigated in 12 healthy subjects.

ExcerptReferenceRelevance
"The pharmacokinetic profile of bromfenac (2-amino-3-(4-bromobenzoyl) benzeneacetic acid, CAS91714-93-1) has been investigated in 12 healthy subjects (6 male and 6 female) after single oral doses of 25, 50 and 75 mg."( Pharmacokinetics of bromfenac in healthy subjects after single oral administration of three different doses.
Högger, P; Rohdewald, P, 1993
)
0.9
"The relationship between pharmacodynamic effect and plasma concentrations of the analgesic bromfenac was assessed retrospectively."( Pharmacokinetic-pharmacodynamic relationships of bromfenac in mice and humans.
Chau, T; Chiang, ST; Ermer, JC; Hicks, D; Osman, M; Vavra, I; Wheeler, S,
)
0.61
" Although statistically significant, the changes in the pharmacokinetic parameters of phenytoin and unbound phenytoin were small."( Evaluation of pharmacokinetic interaction between bromfenac and phenytoin in healthy males.
Cevallos, WH; DeCleene, SA; Gumbhir-Shah, K; Korth-Bradley, JM, 1997
)
0.55
"To compare the pharmacokinetic parameters of bromfenac, a nonsteroidal antiinflammatory drug under development, in healthy volunteers of various ages and either gender, after single and multiple doses."( Effects of age and gender on the pharmacokinetics of bromfenac in healthy volunteers.
Boni, JP; Cevallos, WH; DeCleene, SA; Hicks, DR; Korth-Bradley, JM, 1997
)
0.81
" Pharmacokinetic analysis was performed by noncompartmental techniques."( Effects of age and gender on the pharmacokinetics of bromfenac in healthy volunteers.
Boni, JP; Cevallos, WH; DeCleene, SA; Hicks, DR; Korth-Bradley, JM, 1997
)
0.55
" Significant differences were observed in half-life (t1/2), AUC, clearance, and apparent volume of distribution when the elderly group was compared with the young group and in t1/2 when the elderly group was compared with the young-elderly group, although substantial overlap among groups was observed."( Effects of age and gender on the pharmacokinetics of bromfenac in healthy volunteers.
Boni, JP; Cevallos, WH; DeCleene, SA; Hicks, DR; Korth-Bradley, JM, 1997
)
0.55
" Pharmacokinetic analysis was performed with noncompartmental techniques."( The influence of bromfenac on the pharmacokinetics and pharmacodynamic responses to glyburide in diabetic subjects.
Boni, JP; Cevallos, WH; DeCleene, S; Korth-Bradley, JM,
)
0.47
" The prodrug nepafenac had the shortest time to peak concentration and the greatest peak aqueous humor concentration (C(max))."( In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac.
Ernest, P; Gayton, J; Lehmann, R; Raizman, M; Walters, T, 2007
)
0.56
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"5 hours, and peak concentration (63."( Comparative evaluation of once-daily and twice-daily dosing of topical bromfenac 0.09%: aqueous pharmacokinetics and clinical efficacy study.
Kaur, M; Sinha, R; Thangavel, R; Titiyal, JS; Velpandian, T; Venkatesh, P, 2021
)
0.85

Bioavailability

Nepafenac showed significantly greater ocular bioavailability and amfenac demonstrated greater potency at COX-2 inhibition than ketorolac or bromfenac.

ExcerptReferenceRelevance
"To estimate absolute bioavailability of bromfenac and to compare its pharmacokinetics after intravenous and oral administration."( Absolute bioavailability of bromfenac in humans.
Cevallos, WH; DeCleene, SA; Gumbhir-Shah, K; Halstenson, CE; Korth-Bradley, JM, 1997
)
0.86
"The mean +/- SD absolute bioavailability of bromfenac was 67% +/- 20%."( Absolute bioavailability of bromfenac in humans.
Cevallos, WH; DeCleene, SA; Gumbhir-Shah, K; Halstenson, CE; Korth-Bradley, JM, 1997
)
0.85
"To evaluate the effect of a standard meal on bioavailability of bromfenac, and on the relative analgesic efficacy and adverse effect liability of bromfenac 25 mg, naproxen sodium 550 mg, and acetaminophen 325 mg in the treatment of pain after orthopedic surgery."( The effect of food on bromfenac, naproxen sodium, and acetaminophen in postoperative pain after orthopedic surgery.
Bood-Björklund, L; Forbes, JA; Sandberg, RA,
)
0.68
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
"Nepafenac showed significantly greater ocular bioavailability and amfenac demonstrated greater potency at COX-2 inhibition than ketorolac or bromfenac."( In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac.
Ernest, P; Gayton, J; Lehmann, R; Raizman, M; Walters, T, 2007
)
0.76
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36

Dosage Studied

The higher aqueous concentration sustained with these experimental formulations could broaden the utility of bromfenac and/or reduce the currently approved dosing frequency of this drug. All active treatments were significantly superior to placebo, and the slope of the dose-response curve was significant.

ExcerptRelevanceReference
" The slope of the dose-response curve of bromfenac was significant."( Analgesic efficacy of bromfenac, ibuprofen, and aspirin in postoperative oral surgery pain.
Beaver, WT; Edquist, IA; Forbes, JA; Gongloff, CM; Jones, KF; Schwartz, MK; Smith, FG; Smith, WK, 1992
)
0.86
" All active treatments were significantly superior to placebo, and the slope of the dose-response curve for bromfenac was significant."( Evaluation of bromfenac, aspirin, and ibuprofen in postoperative oral surgery pain.
Beaver, WT; Edquist, IA; Forbes, JA; Schwartz, MK; Smith, FG, 1991
)
0.85
" There was a significant analgesic dose-response for buprenorphine, showing study sensitivity, but not for bromfenac."( Oral bromfenac 10 and 25 mg compared with sublingual buprenorphine 0.2 and 0.4 mg for postoperative pain relief.
Carroll, D; Frankland, T; McQuay, H; Nagle, C, 1993
)
1.01
"These findings suggest that no dosage adjustment is necessary in patients with impaired kidney function, but clinical monitoring appropriate for their individual condition is recommended."( Bromfenac disposition in patients with impaired kidney function.
Berns, JS; Boni, JP; Burghart, P; Cevallos, WH; Cohen, RM; DeCleene, S; Ermer, JC; Fruncillo, RJ; Rudnick, MR, 1997
)
1.74
"The pharmacokinetic parameters of bromfenac were similar after intravenous and oral administration, suggesting that the prototype oral dosage form is optimal and that the observed intersubject variability is due to bromfenac itself, not the type of dosage form."( Absolute bioavailability of bromfenac in humans.
Cevallos, WH; DeCleene, SA; Gumbhir-Shah, K; Halstenson, CE; Korth-Bradley, JM, 1997
)
0.87
"Administration of bromfenac to young-elderly or elderly subjects of either gender does not require a dosage adjustment in acute settings."( Effects of age and gender on the pharmacokinetics of bromfenac in healthy volunteers.
Boni, JP; Cevallos, WH; DeCleene, SA; Hicks, DR; Korth-Bradley, JM, 1997
)
0.88
" The treatment groups included placebo (n = 21) and bromfenac (n = 102) at dosage strengths of 5 mg (n = 21), 25 mg (n = 20), 50 mg (n = 20), 100 mg (n = 20), and 200 mg (n = 21)."( A dose-ranging study of bromfenac sodium in oral surgery pain.
Betts, NJ; Cooper, SA; Hersh, EV; Lamp, C; Levin, LM; Wajdula, J; Wedell, D, 1998
)
0.86
" Peak analgesic effects did not increase beyond those provided by the 25-mg dose of bromfenac, although both the 100- and 200-mg bromfenac doses provided a more rapid onset and a longer duration of analgesia than either the 25- or 50-mg dosage strengths."( A dose-ranging study of bromfenac sodium in oral surgery pain.
Betts, NJ; Cooper, SA; Hersh, EV; Lamp, C; Levin, LM; Wajdula, J; Wedell, D, 1998
)
0.83
"Bromfenac is a safe and efficacious analgesic, with a threshold dose of 5 mg and a positive dose-response up to 25 mg for peak effects and 100 mg for total analgesic activity."( A dose-ranging study of bromfenac sodium in oral surgery pain.
Betts, NJ; Cooper, SA; Hersh, EV; Lamp, C; Levin, LM; Wajdula, J; Wedell, D, 1998
)
2.05
" Renal disease, hepatic disease and aging alter the disposition kinetics of bromfenac, and dosage adjustment may be advisable."( Clinical pharmacokinetics and pharmacodynamics of bromfenac.
Davies, NM; Skjodt, NM, 1999
)
0.79
" There was no dose-response relationship for bromfenac."( Comparison of tilidine/naloxone, tramadol and bromfenac in experimental pain: a double-blind randomized crossover study in healthy human volunteers.
Högger, P; Rohdewald, P, 1999
)
0.82
"09% 6 hours and 12 hours preoperatively consistent with on-label dosing schedules."( Comparison of ketorolac 0.4% and bromfenac 0.09% at trough dosing: aqueous drug absorption and prostaglandin E2 levels.
Bucci, FA; Waterbury, LD, 2008
)
0.63
" The mean aqueous concentration of ketorolac and bromfenac at trough dosing was 130."( Comparison of ketorolac 0.4% and bromfenac 0.09% at trough dosing: aqueous drug absorption and prostaglandin E2 levels.
Bucci, FA; Waterbury, LD, 2008
)
0.88
" Bromfenac remained above the IC(50) value of cyclo-oxygenase-2 (COX-2) during the evaluated time points and over the 12-h dosing interval, using a computer model of extrapolated time points and assuming first-order elimination."( Ocular pharmacokinetics of a single dose of bromfenac sodium ophthalmic solution 0.1% in human aqueous humor.
Gow, JA; McNamara, TR; Miyake, K; Ogawa, T; Tajika, T, 2008
)
1.52
") dosing regimen."( Aqueous prostaglandin E(2) of cataract patients at trough ketorolac and bromfenac levels after 2 days dosing.
Bucci, FA; Waterbury, LD, 2009
)
0.59
" Bromfenac dosed twice-daily was clearly superior to placebo for postoperative pain and inflammation in a large, controlled trial and compares favorably with other NSAIDs in smaller studies."( Ophthalmic utility of topical bromfenac, a twice-daily nonsteroidal anti-inflammatory agent.
Francis, P; Jones, J, 2009
)
1.55
" The higher aqueous concentration sustained with these experimental formulations could broaden the utility of bromfenac and/or reduce the currently approved dosing frequency of this drug."( Pharmacokinetic comparisons of bromfenac in DuraSite and Xibrom.
Bowman, LM; Hosseini, K; Si, EC, 2011
)
0.87
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
"09% dosed once daily for the treatment of ocular inflammation and pain following cataract extraction with posterior chamber intraocular lens implantation."( Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain.
Cable, MG; Chandler, SP; Fong, R; Gow, JA; Klier, SM; McNamara, TR; Peace, JH; Sadri, E; Silverstein, SM, 2011
)
0.69
"09% or placebo dosed once daily."( Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain.
Cable, MG; Chandler, SP; Fong, R; Gow, JA; Klier, SM; McNamara, TR; Peace, JH; Sadri, E; Silverstein, SM, 2011
)
0.69
"09% dosed once daily is clinically safe and effective for the treatment of ocular inflammation and the reduction of ocular pain associated with cataract surgery."( Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain.
Cable, MG; Chandler, SP; Fong, R; Gow, JA; Klier, SM; McNamara, TR; Peace, JH; Sadri, E; Silverstein, SM, 2011
)
0.69
"09% dosed once daily for the treatment of ocular inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation."( Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain.
Chandler, SP; Gayton, JL; Gow, JA; Henderson, BA; Klier, SM; McNamara, TR, 2011
)
0.68
"09% or placebo dosed once daily beginning 1 day before cataract surgery (day -1), continuing on the day of surgery (day 0), and continuing for an additional postoperative 14 days."( Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain.
Chandler, SP; Gayton, JL; Gow, JA; Henderson, BA; Klier, SM; McNamara, TR, 2011
)
0.68
"09% dosed once daily was clinically safe and effective for reducing and treating ocular inflammation and pain associated with cataract surgery."( Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain.
Chandler, SP; Gayton, JL; Gow, JA; Henderson, BA; Klier, SM; McNamara, TR, 2011
)
0.68
" On-label dosing of ketorolac (BID), bromfenac (BID), and nepafenac (TID) was instructed for 1 day prior to surgery."( A randomized comparison of to-aqueous penetration of ketorolac 0.45%, bromfenac 0.09% and nepafenac 0.1% in cataract patients undergoing phacoemulsification.
Bucci, FA; Waterbury, LD, 2011
)
0.88
"1% at peak dosing levels in patients previously scheduled to undergo phacoemulsification."( Prostaglandin E2 inhibition of ketorolac 0.45%, bromfenac 0.09%, and nepafenac 0.1% in patients undergoing phacoemulsification.
Bucci, FA; Waterbury, LD, 2011
)
0.62
" Patients were instructed to take the NSAID per on-label dosing (twice daily [b."( Prostaglandin E2 inhibition of ketorolac 0.45%, bromfenac 0.09%, and nepafenac 0.1% in patients undergoing phacoemulsification.
Bucci, FA; Waterbury, LD, 2011
)
0.62
"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."( Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials.
Goldberg, DF; Gow, JA; Peace, JH; Walters, TR, 2014
)
1.85
"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)."( Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials.
Goldberg, DF; Gow, JA; Peace, JH; Walters, TR, 2014
)
1.85
"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."( Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials.
Goldberg, DF; Gow, JA; Peace, JH; Walters, TR, 2014
)
1.85
"Both groups demonstrated similar effectiveness and safety between dosing regimens."( Comparison of 2 regimens of loteprednol etabonate and bromfenac for cataract surgery.
Al-Awadi, A; Chan, CC; Somani, S; Tokko, HA, 2019
)
0.76
" The compliance questionnaire also suggests a patient preference for the dosing regimen with lower frequency of drop application."( Comparison of 2 regimens of loteprednol etabonate and bromfenac for cataract surgery.
Al-Awadi, A; Chan, CC; Somani, S; Tokko, HA, 2019
)
0.76
"09% and compare clinical outcomes of once- and twice-daily dosing in phacoemulsification."( Comparative evaluation of once-daily and twice-daily dosing of topical bromfenac 0.09%: aqueous pharmacokinetics and clinical efficacy study.
Kaur, M; Sinha, R; Thangavel, R; Titiyal, JS; Velpandian, T; Venkatesh, P, 2021
)
0.85
" Cumulative effect was observed with repeated dosing with aqueous levels more than IC50 in once-daily and twice-daily groups at 5 days."( Comparative evaluation of once-daily and twice-daily dosing of topical bromfenac 0.09%: aqueous pharmacokinetics and clinical efficacy study.
Kaur, M; Sinha, R; Thangavel, R; Titiyal, JS; Velpandian, T; Venkatesh, P, 2021
)
0.85
" Clinical efficacy of once-daily and twice-daily dosing was comparable."( Comparative evaluation of once-daily and twice-daily dosing of topical bromfenac 0.09%: aqueous pharmacokinetics and clinical efficacy study.
Kaur, M; Sinha, R; Thangavel, R; Titiyal, JS; Velpandian, T; Venkatesh, P, 2021
)
0.85
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
non-steroidal anti-inflammatory drugAn anti-inflammatory drug that is not a steroid. In addition to anti-inflammatory actions, non-steroidal anti-inflammatory drugs have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins.
non-narcotic analgesicA drug that has principally analgesic, antipyretic and anti-inflammatory actions. Non-narcotic analgesics do not bind to opioid receptors.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
benzophenonesAny aromatic ketone in which the carbonyl group is bonded to 2 phenyl groups.
substituted aniline
aromatic amino acidAn amino acid whose structure includes an aromatic ring.
organobromine compoundA compound containing at least one carbon-bromine bond.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Bromfenac Action Pathway2967

Protein Targets (5)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Prostaglandin G/H synthase 1Homo sapiens (human)IC50 (µMol)0.00850.00021.557410.0000AID625243
Prostaglandin G/H synthase 2Homo sapiens (human)IC50 (µMol)0.00480.00010.995010.0000AID625244
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (94)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
prostaglandin biosynthetic processProstaglandin G/H synthase 1Homo sapiens (human)
response to oxidative stressProstaglandin G/H synthase 1Homo sapiens (human)
regulation of blood pressureProstaglandin G/H synthase 1Homo sapiens (human)
cyclooxygenase pathwayProstaglandin G/H synthase 1Homo sapiens (human)
regulation of cell population proliferationProstaglandin G/H synthase 1Homo sapiens (human)
cellular oxidant detoxificationProstaglandin G/H synthase 1Homo sapiens (human)
prostaglandin biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
angiogenesisProstaglandin G/H synthase 2Homo sapiens (human)
response to oxidative stressProstaglandin G/H synthase 2Homo sapiens (human)
embryo implantationProstaglandin G/H synthase 2Homo sapiens (human)
learningProstaglandin G/H synthase 2Homo sapiens (human)
memoryProstaglandin G/H synthase 2Homo sapiens (human)
regulation of blood pressureProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of cell population proliferationProstaglandin G/H synthase 2Homo sapiens (human)
response to xenobiotic stimulusProstaglandin G/H synthase 2Homo sapiens (human)
response to nematodeProstaglandin G/H synthase 2Homo sapiens (human)
response to fructoseProstaglandin G/H synthase 2Homo sapiens (human)
response to manganese ionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of vascular endothelial growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
cyclooxygenase pathwayProstaglandin G/H synthase 2Homo sapiens (human)
bone mineralizationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of prostaglandin biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of fever generationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of synaptic plasticityProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of synaptic transmission, dopaminergicProstaglandin G/H synthase 2Homo sapiens (human)
prostaglandin secretionProstaglandin G/H synthase 2Homo sapiens (human)
response to estradiolProstaglandin G/H synthase 2Homo sapiens (human)
response to lipopolysaccharideProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of peptidyl-serine phosphorylationProstaglandin G/H synthase 2Homo sapiens (human)
response to vitamin DProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to heatProstaglandin G/H synthase 2Homo sapiens (human)
response to tumor necrosis factorProstaglandin G/H synthase 2Homo sapiens (human)
maintenance of blood-brain barrierProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of protein import into nucleusProstaglandin G/H synthase 2Homo sapiens (human)
hair cycleProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of apoptotic processProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of nitric oxide biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of cell cycleProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of vasoconstrictionProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of smooth muscle contractionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of smooth muscle contractionProstaglandin G/H synthase 2Homo sapiens (human)
decidualizationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of smooth muscle cell proliferationProstaglandin G/H synthase 2Homo sapiens (human)
regulation of inflammatory responseProstaglandin G/H synthase 2Homo sapiens (human)
brown fat cell differentiationProstaglandin G/H synthase 2Homo sapiens (human)
response to glucocorticoidProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of calcium ion transportProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of synaptic transmission, glutamatergicProstaglandin G/H synthase 2Homo sapiens (human)
response to fatty acidProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to mechanical stimulusProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to lead ionProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to ATPProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to hypoxiaProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to non-ionic osmotic stressProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to fluid shear stressProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of transforming growth factor beta productionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of cell migration involved in sprouting angiogenesisProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of fibroblast growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of brown fat cell differentiationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of platelet-derived growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
cellular oxidant detoxificationProstaglandin G/H synthase 2Homo sapiens (human)
regulation of neuroinflammatory responseProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to osmotic stressProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to homocysteineProstaglandin G/H synthase 2Homo sapiens (human)
response to angiotensinProstaglandin G/H synthase 2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (29)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
peroxidase activityProstaglandin G/H synthase 1Homo sapiens (human)
prostaglandin-endoperoxide synthase activityProstaglandin G/H synthase 1Homo sapiens (human)
protein bindingProstaglandin G/H synthase 1Homo sapiens (human)
heme bindingProstaglandin G/H synthase 1Homo sapiens (human)
metal ion bindingProstaglandin G/H synthase 1Homo sapiens (human)
oxidoreductase activity, acting on single donors with incorporation of molecular oxygen, incorporation of two atoms of oxygenProstaglandin G/H synthase 1Homo sapiens (human)
peroxidase activityProstaglandin G/H synthase 2Homo sapiens (human)
prostaglandin-endoperoxide synthase activityProstaglandin G/H synthase 2Homo sapiens (human)
protein bindingProstaglandin G/H synthase 2Homo sapiens (human)
enzyme bindingProstaglandin G/H synthase 2Homo sapiens (human)
heme bindingProstaglandin G/H synthase 2Homo sapiens (human)
protein homodimerization activityProstaglandin G/H synthase 2Homo sapiens (human)
metal ion bindingProstaglandin G/H synthase 2Homo sapiens (human)
oxidoreductase activity, acting on single donors with incorporation of molecular oxygen, incorporation of two atoms of oxygenProstaglandin G/H synthase 2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (28)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
photoreceptor outer segmentProstaglandin G/H synthase 1Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 1Homo sapiens (human)
endoplasmic reticulum membraneProstaglandin G/H synthase 1Homo sapiens (human)
Golgi apparatusProstaglandin G/H synthase 1Homo sapiens (human)
intracellular membrane-bounded organelleProstaglandin G/H synthase 1Homo sapiens (human)
extracellular exosomeProstaglandin G/H synthase 1Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 1Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 1Homo sapiens (human)
nuclear inner membraneProstaglandin G/H synthase 2Homo sapiens (human)
nuclear outer membraneProstaglandin G/H synthase 2Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulumProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulum lumenProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulum membraneProstaglandin G/H synthase 2Homo sapiens (human)
caveolaProstaglandin G/H synthase 2Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 2Homo sapiens (human)
protein-containing complexProstaglandin G/H synthase 2Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 2Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (68)

Assay IDTitleYearJournalArticle
AID1774076Inhibition of 8-anilinonaphthalene-l-sulfonic acid binding to TTR V3OM mutant (unknown origin) expressed in Escherichia coli at 400 uM incubated for 1 hr in presence of 75 uM ANS by fluorescence method (Rvb = 91 +/- 0.92%)2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID625293Drug Induced Liver Injury Prediction System (DILIps) validation dataset; compound DILI positive/negative as observed in LTKB-BD2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1774079Stabilization of TTR V3OM mutant (unknown origin) assessed as acid-mediated protein aggregation inhibition ratio at 10 uM incubated for 1 week by absorbance method2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID29813Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID625295Drug Induced Liver Injury Prediction System (DILIps) validation dataset; compound DILI positive/negative as observed in Pfizer data2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID28681Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID29359Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1636440Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID625276FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of most concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1774078Stabilization of TTR V3OM mutant (unknown origin) assessed as acid-mediated protein aggregation inhibition ratio at 4 uM incubated for 1 week by absorbance method2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1774075Inhibition of 8-anilinonaphthalene-l-sulfonic acid binding to TTR V3OM mutant (unknown origin) expressed in Escherichia coli assessed as ANS saturation ratio at 400 uM incubated for 1 hr in presence of 7.5 uM ANS by fluorescence method (Rvb = 56 +/- 2.3%)2021Journal of medicinal chemistry, 10-14, Volume: 64, Issue:19
Repositioning of the Anthelmintic Drugs Bithionol and Triclabendazole as Transthyretin Amyloidogenesis Inhibitors.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID27167Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1473835Stimulation of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID977610Experimentally measured binding affinity data (Ki) for protein-ligand complexes derived from PDB2014Chemistry & biology, Apr-24, Volume: 21, Issue:4
DNA replication is the target for the antibacterial effects of nonsteroidal anti-inflammatory drugs.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (176)

TimeframeStudies, This Drug (%)All Drugs %
pre-19905 (2.84)18.7374
1990's30 (17.05)18.2507
2000's38 (21.59)29.6817
2010's79 (44.89)24.3611
2020's24 (13.64)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 74.16

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index74.16 (24.57)
Research Supply Index5.61 (2.92)
Research Growth Index5.31 (4.65)
Search Engine Demand Index128.86 (26.88)
Search Engine Supply Index2.02 (0.95)

This Compound (74.16)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials78 (40.41%)5.53%
Reviews11 (5.70%)6.00%
Case Studies12 (6.22%)4.05%
Observational2 (1.04%)0.25%
Other90 (46.63%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (54)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Topical 0.1% Bromfenac Sodium for Intraoperative Pupil Dilation Maintenance and Prostaglandin E2 Inhibition in Femtosecond Laser-assisted Cataract Surgery [NCT02681679]60 participants (Actual)Interventional2014-10-31Completed
Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Si [NCT03886779]Phase 457 participants (Actual)Interventional2013-10-30Completed
Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification [NCT03106402]316 participants (Actual)Observational2013-10-01Completed
An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management [NCT03751059]Phase 4150 participants (Anticipated)Interventional2020-11-30Not yet recruiting
The Effect of Topical Corticosteroids and Topical NSAIDs Perioperatively on IL6 Levels in Aqueous Humor and on Incidence of PCME in Patients With NPDR [NCT04940338]Phase 490 participants (Actual)Interventional2021-05-01Completed
Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation [NCT05107921]Phase 239 participants (Anticipated)Interventional2021-11-01Recruiting
The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study [NCT02137161]Phase 462 participants (Actual)Interventional2013-11-30Completed
Efficacy and Safety of PRO-155 (Zebesten Ofteno®) on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo. [NCT03521791]Phase 4166 participants (Actual)Interventional2017-12-13Completed
Comparison Between Grid Macular Laser and Topical Bromfenac 0.09% in the Treatment of Diabetic Macular Edema [NCT05715385]Phase 460 participants (Actual)Interventional2014-11-30Completed
Bromfenac 0.09% Versus Dexamethasone 0.1% Ophthalmic Solutions to Reduce Inflammation After Cataract Surgery [NCT03317847]Phase 476 participants (Actual)Interventional2017-10-16Completed
Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection. [NCT06130384]Phase 4139 participants (Anticipated)Interventional2021-03-01Recruiting
Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery. [NCT01367249]Phase 3440 participants (Actual)Interventional2011-05-31Completed
Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1% [NCT02361645]Phase 370 participants (Actual)Interventional2014-03-31Completed
A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone [NCT00698724]Phase 4200 participants (Anticipated)Interventional2008-06-30Completed
[NCT00853970]Phase 3299 participants (Actual)Interventional2009-02-28Completed
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery [NCT00758199]Phase 449 participants (Actual)Interventional2008-07-31Completed
Evaluation of Comfort With the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Xibrom (Bromfenac Ophthalmic Solution) 0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT) [NCT00828477]Phase 425 participants (Anticipated)Interventional2009-01-31Completed
Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen [NCT03578276]Phase 435 participants (Actual)Interventional2018-06-22Completed
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 [NCT01310127]Phase 423 participants (Actual)Interventional2010-11-30Completed
[NCT00585975]Phase 2568 participants (Actual)Interventional2007-10-31Completed
Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration [NCT00805233]Phase 230 participants (Anticipated)Interventional2008-12-31Completed
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification [NCT01021761]Phase 4126 participants (Actual)Interventional2009-10-31Completed
Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema. [NCT00438243]Phase 20 participants (Actual)Interventional2008-05-31Withdrawn(stopped due to Principal Investigator left institution)
[NCT00469781]Phase 495 participants (Actual)Interventional2007-05-31Completed
Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery [NCT03831984]Phase 460 participants (Actual)Interventional2018-03-01Enrolling by invitation
Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients [NCT00520260]Phase 442 participants (Actual)Interventional2007-08-31Completed
[NCT00595543]Phase 4166 participants (Anticipated)Interventional2008-01-31Completed
Bromday (Bromfenac Ophthalmic Solution)0.09% QD vs Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Control of Pain and Epithelial Healing Post (PRK) [NCT01475877]20 participants (Actual)Observational2011-05-31Completed
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients [NCT00347503]Phase 40 participants InterventionalCompleted
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects [NCT00469690]Phase 458 participants (Actual)Interventional2007-05-31Completed
[NCT00758784]Phase 238 participants (Actual)Interventional2008-08-13Completed
A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™ Once Daily (QD) Prior To Cataract Surgery [NCT01387464]Phase 260 participants (Actual)Interventional2011-07-31Completed
A Single-Center, Investigator-Sponsored Pilot Study to Assess Safety and Biologic Activity of Bromfenac Ophthalmic Solution, 0.09%, in Subjects With Diffuse DME Refractory to Laser [NCT00491166]Phase 110 participants (Anticipated)Interventional2007-06-30Recruiting
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With a History of Allergic Conjunctivitis [NCT00423007]Phase 390 participants Interventional2006-11-30Completed
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery [NCT00198445]Phase 3527 participants (Actual)Interventional2003-05-31Completed
A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification [NCT01001806]Phase 4126 participants (Actual)Interventional2009-10-31Completed
Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery [NCT00333918]Phase 3522 participants (Actual)Interventional2006-06-30Completed
PRevention of Macular EDema After Cataract Surgery [NCT01774474]Phase 31,127 participants (Actual)Interventional2013-07-10Completed
Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers. [NCT01535443]Phase 135 participants (Actual)Interventional2011-09-30Completed
A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects [NCT01576952]Phase 3268 participants (Actual)Interventional2012-07-31Completed
[NCT01212471]Phase 3840 participants (Actual)Interventional2010-09-30Completed
A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects [NCT01808547]Phase 3268 participants (Actual)Interventional2013-05-31Completed
A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers [NCT01190878]Phase 1/Phase 2169 participants (Actual)Interventional2010-08-31Completed
[NCT00704418]Phase 3156 participants (Actual)Interventional2008-06-30Completed
[NCT00377546]Phase 40 participants InterventionalCompleted
Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals [NCT05001243]Phase 111 participants (Anticipated)Interventional2021-08-10Recruiting
[NCT00703781]Phase 3126 participants (Actual)Interventional2008-06-30Completed
Control of Pain in Intravitreal Injections (COPIVIN Study): A Study Evaluating the Use of Combination Topical Anesthetic and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) [NCT04343222]Phase 446 participants (Actual)Interventional2019-06-27Completed
Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients [NCT03597867]Phase 3104 participants (Actual)Interventional2018-04-25Completed
Bromfenac Ophthalmic Solution 0.1% for Postoperative Ocular Pain and Inflammation Related To Pterygium Surgery [NCT04022811]Phase 460 participants (Actual)Interventional2016-10-31Completed
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID [NCT01023724]Phase 450 participants (Actual)Interventional2009-12-31Completed
Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia [NCT05006911]Phase 111 participants (Anticipated)Interventional2021-08-14Recruiting
Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD for Treatment of Ocular Inflammation Associated With Cataract Surgery [NCT01847638]50 participants (Actual)Interventional2013-04-01Completed
The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery [NCT05158699]Phase 3808 participants (Anticipated)Interventional2021-10-13Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00585975 (2) [back to overview]Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
NCT00585975 (2) [back to overview]Number of Participants That Are Pain Free
NCT00703781 (2) [back to overview]Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
NCT00703781 (2) [back to overview]Number of Participants That Are Pain Free
NCT00704418 (2) [back to overview]Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
NCT00704418 (2) [back to overview]Number of Participants That Are Pain Free
NCT00758784 (3) [back to overview]Percentage of Participants With at Least One Adverse Event
NCT00758784 (3) [back to overview]Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
NCT00758784 (3) [back to overview]Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
NCT00853970 (2) [back to overview]Pain Free
NCT00853970 (2) [back to overview]Summed Ocular Inflammation Score (SOIS) of Zero
NCT01001806 (1) [back to overview]Peak Aqueous Penetration
NCT01021761 (1) [back to overview]Aqueous PGE2 Inhibition
NCT01023724 (1) [back to overview]Anterior Chamber Inflammation (Flare)
NCT01190878 (1) [back to overview]Ocular Inflammation
NCT01212471 (1) [back to overview]Mean Ocular Surface Disease Index (OSDI) Total Score
NCT01310127 (4) [back to overview]Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities
NCT01310127 (4) [back to overview]Macular Volume
NCT01310127 (4) [back to overview]OCT Retinal Thickness
NCT01310127 (4) [back to overview]Summed Ocular Inflammation Score (SOIS)
NCT01367249 (2) [back to overview]Ocular Pain
NCT01367249 (2) [back to overview]Ocular Inflammation
NCT01387464 (1) [back to overview]Mean Aqueous Humor Bromfenac Concentration
NCT01535443 (12) [back to overview]Chemosis
NCT01535443 (12) [back to overview]Corneal Damage by Fluorescein Staining Test
NCT01535443 (12) [back to overview]Corneal Damage by Lissamine Green Staining Test
NCT01535443 (12) [back to overview]Findings in Posterior Segment
NCT01535443 (12) [back to overview]Burning
NCT01535443 (12) [back to overview]Adverse Events
NCT01535443 (12) [back to overview]Foreign Body Sensation
NCT01535443 (12) [back to overview]Hyperemia
NCT01535443 (12) [back to overview]Intraocular Pressure (IOP)
NCT01535443 (12) [back to overview]Photophobia
NCT01535443 (12) [back to overview]Tearing
NCT01535443 (12) [back to overview]Visual Acuity
NCT01576952 (1) [back to overview]Ocular Inflammation
NCT01808547 (1) [back to overview]Ocular Inflammation
NCT01847638 (3) [back to overview]Visual Acuity
NCT01847638 (3) [back to overview]Retinal Thickness
NCT01847638 (3) [back to overview]Treatment of Inflammation Associated With Cataract Surgery
NCT03521791 (9) [back to overview]Breakup Time (BUT)
NCT03521791 (9) [back to overview]Epithelial Defects (ED) Green Lissamine
NCT03521791 (9) [back to overview]Visual Capacity
NCT03521791 (9) [back to overview]Presence of Adverse Events (EAS)
NCT03521791 (9) [back to overview]Number of Eyes With Ocular Burning (OB)
NCT03521791 (9) [back to overview]Conjunctival Hyperemia (CH)
NCT03521791 (9) [back to overview]Number of Eyes With Foreign Body Sensation (FBS)
NCT03521791 (9) [back to overview]Number of Eyes With Chemosis
NCT03521791 (9) [back to overview]Intraocular Pressure (IOP)
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT04343222 (6) [back to overview]McGill Pain Questionnaire (SF-MPQ) Scores at 24 Hours Post Injection
NCT04343222 (6) [back to overview]McGill Pain Questionnaire (SF-MPQ) Scores at 6 Hours Post Injection
NCT04343222 (6) [back to overview]Wong-Baker FACES Pain Scale Scores at 24 Hours Post Injection
NCT04343222 (6) [back to overview]Wong-Baker FACES Pain Scale Scores at 6 Hours Post Injection
NCT04343222 (6) [back to overview]Wong-Baker FACES Pain Scale Scores at Baseline
NCT04343222 (6) [back to overview]McGill Pain Questionnaire (SF-MPQ) Scores at Baseline

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) (NCT00585975)
Timeframe: Day 15

InterventionParticipant (Number)
Bromfenac Ophthalmic Solution 0.18%157
Xibrom 0.09%164

[back to top]

Number of Participants That Are Pain Free

Participant description of being pain free taken from patient questionnaire with multiple possible responses (NCT00585975)
Timeframe: Day 1

InterventionParticipant (Number)
Bromfenac Ophthalmic Solution 0.18%221
Xibrom 0.09%235

[back to top]

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) (NCT00703781)
Timeframe: Day 15

InterventionParticipants (Number)
Bromfenac28
Placebo20

[back to top]

Number of Participants That Are Pain Free

Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop (NCT00703781)
Timeframe: Day 1

InterventionParticipants (Number)
Bromfenac51
Placebo46

[back to top]

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) (NCT00704418)
Timeframe: Day 15

Interventionparticipants (Number)
Bromfenac36
Placebo23

[back to top]

Number of Participants That Are Pain Free

Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses (NCT00704418)
Timeframe: Day 1

Interventionparticipants (Number)
Bromfenac65
Placebo40

[back to top]

Percentage of Participants With at Least One Adverse Event

(NCT00758784)
Timeframe: 52 days

InterventionParticipants (Count of Participants)
Bromfenac Ophthalmic Solution 0.06%9

[back to top]

Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye

Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria. (NCT00758784)
Timeframe: Baseline, 42 days

Interventionscore on a scale (Mean)
Bromfenac Ophthalmic Solution 0.06%-0.84

[back to top]

Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye

Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria. (NCT00758784)
Timeframe: Baseline, Day 42

Interventionscore on a scale (Mean)
Bromfenac Ophthalmic Solution 0.06%-0.65

[back to top]

Pain Free

Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe. (NCT00853970)
Timeframe: Day 1

Interventionparticipants (Number)
Bromfenac Ophthalmic Solution 0.09%135
Placebo105

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Summed Ocular Inflammation Score (SOIS) of Zero

Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) (NCT00853970)
Timeframe: Day 15 (Primary Endpoint)

Interventionparticipants (Number)
Bromfenac Ophthalmic Solution 0.09%70
Placebo36

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Peak Aqueous Penetration

(NCT01001806)
Timeframe: day 4 of treatment

Interventionng/ml (Mean)
Acuvail688.87
Xibrom67.64
Nevanac447.1

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Aqueous PGE2 Inhibition

A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection. (NCT01021761)
Timeframe: Day 4 of treatment

Interventionpg/ml (Mean)
Xibrom288.7
Nevanac320.4
Acuvail224.8

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Anterior Chamber Inflammation (Flare)

Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber. (NCT01023724)
Timeframe: Day 14 of treatment

Interventionphoton count per msec (pc/ms) (Mean)
Xibrom24.48
Acuvail21.93

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Ocular Inflammation

"Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells." (NCT01190878)
Timeframe: 15 days

Interventionparticipants (Number)
ISV-303 BID21
ISV-303 QD24
Xibrom BID18
DuraSite Vehicle BID8

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Mean Ocular Surface Disease Index (OSDI) Total Score

The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes. (NCT01212471)
Timeframe: 42 days

Interventionscore on a scale (Mean)
Bromfenac Ophthalmic Solution 0.06%35.0
Bromfenac Ophthalmic Solution 0.03%40.3
Placebo Comparator36.9

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Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities

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. (NCT01310127)
Timeframe: Week 6

Interventionletters (Mean)
Bromday51.3
Nevanac52

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Macular Volume

Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength (NCT01310127)
Timeframe: 6 weeks

Interventionmm cubed (Mean)
Bromday0.1815
Nevanac0.1765

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OCT Retinal Thickness

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. (NCT01310127)
Timeframe: Week 6

Interventionmicrometers cubed (Mean)
Bromday230.7
Nevanac223.8

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Summed Ocular Inflammation Score (SOIS)

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). (NCT01310127)
Timeframe: Week 6

Interventionunits on a scale (Mean)
Bromday0.15
Nevanac0.2

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Ocular Pain

"The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of None on the pain scale of the Ocular Comfort Grading Assessment in the subject diary." (NCT01367249)
Timeframe: Day 1

Interventioneyes (Number)
Bromfenac Ophthalmic Solution175
Placebo108

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Ocular Inflammation

The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15. (NCT01367249)
Timeframe: Day 15

Interventioneyes (Number)
Bromfenac Ophthalmic Solution108
Placebo53

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Mean Aqueous Humor Bromfenac Concentration

(NCT01387464)
Timeframe: Approximately 3 hours post last dose

Interventionng/mL (Mean)
ISV-30349.3
Bromday23.7

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Chemosis

chemosis will be reported according to the following scale: absent, mild, moderate and severe. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eye : absentright eye : mildright eye : moderateright eye : severeleft eye : absentleft eye : mildleft eye : moderateleft eye : severeleft eye : Missing dataright eye : Missing data
PRO-155 Ophthalmic Solution 0.09 %340003400011

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Corneal Damage by Fluorescein Staining Test

Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eye : absentright eye : mildright eye : moderateright eye : severeleft eye : absentleft eye : mildleft eye : moderateleft eye : severeleft eye : Missing dataright eye : Missing data
PRO-155 Ophthalmic Solution 0.09 %340003400011

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Corneal Damage by Lissamine Green Staining Test

Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eye : absentright eye : mildright eye : moderateright eye : severeleft eye : absentleft eye : mildleft eye : moderateleft eye : severeleft eye : Missing dataright eye : Missing data
PRO-155 Ophthalmic Solution 0.09 %340003400011

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Findings in Posterior Segment

Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings. (NCT01535443)
Timeframe: 10 days

Interventionabnormal findings (Number)
right eyeleft eye
PRO-155 Ophthalmic Solution 0.09 %11

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Burning

Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eye : absentright eye : mildright eye : moderateright eye : severeleft eye : absentleft eye : mildleft eye : moderateleft eye : severe
PRO-155 Ophthalmic Solution 0.09 %3400033001

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Adverse Events

will be reported the presence of adverse events presented in the study group during the intervention period . (NCT01535443)
Timeframe: 10 days

Interventionevents (Number)
PRO-155 Ophthalmic Solution 0.09 %1

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Foreign Body Sensation

Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eye : absentright eye : mildright eye : moderateright eye : severeleft eye : absentleft eye : mildleft eye : moderateleft eye : severeleft eye: Missing dataright eye : Missing data
PRO-155 Ophthalmic Solution 0.09 %340003400011

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Hyperemia

The red eye will be evaluated by the absence or presence of hyperemia. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eyeleft eye
PRO-155 Ophthalmic Solution 0.09 %00

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Intraocular Pressure (IOP)

Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg. (NCT01535443)
Timeframe: 10 days

Interventionmillimeters of mercury (mmhg) (Mean)
right ayeleft eye
PRO-155 Ophthalmic Solution 0.09 %13.313.4

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Photophobia

photophobia will be reported according to the following scale: absent, mild, moderate and severe. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eye : absentright eye : mildright eye : moderateright eye : severeleft eye : absentleft eye : mildleft eye : moderateleft eye : severeleft eye : Missing dataright eye : Missing data
PRO-155 Ophthalmic Solution 0.09 %340003400011

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Tearing

Tearing will be reported according to the following scale: absent, mild, moderate and severe. (NCT01535443)
Timeframe: 10 days

Interventioneyes (Number)
right eye : absentright eye : mildright eye : moderateright eye : severeleft eye : absentleft eye : mildleft eye : moderateleft eye : severeleft eye : Missing dataright eye : Missing data
PRO-155 Ophthalmic Solution 0.09 %340003400011

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Visual Acuity

A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst (NCT01535443)
Timeframe: 10 days

Interventionunits on a scale (Mean)
right eyeleft eye
PRO-155 Ophthalmic Solution 0.09 %20.320.2

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Ocular Inflammation

"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications." (NCT01576952)
Timeframe: 15 days

Interventionparticipants (Number)
ISV-30396
Vehicle16

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Ocular Inflammation

"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications." (NCT01808547)
Timeframe: 15 days

Interventionparticipants (Number)
ISV-30364
Vehicle19

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Visual Acuity

ETDRS log MAR Visual Acuity from baseline to final postoperative visit. The change was calculated as the difference of the value at the later time point minus the value at the earlier time point. The scale runs from -0.30 (corresponding to 20/10) or better visual acuity to 1(20/200) or worse visual acuity with the smaller or more negative numbers indicating better visual acuity outcomes and larger numbers indicating worsened visual acuity outcomes. (NCT01847638)
Timeframe: baseline score to final postoperative visit at 42 days +/-7 days

InterventionlogMar (Mean)
Prolensa (Bromfenac 0.07%).19
Ilevro (Nepafenac 0.3%).21

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Retinal Thickness

Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT (NCT01847638)
Timeframe: change from baseline to final postoperative visit at 42 days +/- 7 days

Interventionmicrons (Mean)
Prolensa (Bromfenac 0.07%)276
Ilevro (Nepafenac 0.3%)279

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Treatment of Inflammation Associated With Cataract Surgery

Units on a scale. Biomicroscopy with slit lamp beam of 0.3 mm in width and 1.0 mm in height will be used to determine anterior cell and flare scores at each study visit by counting each individual white blood cell present and grading the flare (measure of protein and marker of inflammation in aqueous fluid). The sum of the severity of cell count and the flare grade will be called the Summed Ocular Inflammation Score (SOIS) and measured at each time point. The scale is 0-4 range for both values cells counted and flare where 0=no cell and 0=complete abscence of flare; 0.5 = 1-5 cells (trace) and 0= no flare; 1=6-15 cells and 1=very slight (barely detectable ) flare, 2=16-25 cells and 2=moderate flare (iris and lens clear), 3=26-30 cells and 3 =marked (iris and lens hazy) and 4=> (NCT01847638)
Timeframe: change from baseline to final at post op 42 days +/-7 days

Interventionunits on a scale (Mean)
Prolensa (Bromfenac 0.07%)0.01
Ilevro (Nepafenac 0.3%)0.01

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Breakup Time (BUT)

breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds. (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

Interventionseconds (Mean)
PRO-1558.29
Placebo7.63

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Epithelial Defects (ED) Green Lissamine

The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

,
Interventioneyes (Count of Units)
Green lissamine grade 0Green lissamine grade 1Green lissamine grade 2Green lissamine grade 3Green lissamine grade 4Green lissamine grade 5
Placebo44218000
PRO-15541214300

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Visual Capacity

The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20. (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

InterventionLogMAR (Mean)
PRO-1550.043
Placebo0.059

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Presence of Adverse Events (EAS)

primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. Adverse events that are reported until the safety call to the 36th day of the study will be considered for this variable (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 36)

InterventionParticipants (Count of Participants)
PRO-15513
Placebo19

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Number of Eyes With Ocular Burning (OB)

"primary tolerability variable~Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time." (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

Interventioneyes (Count of Units)
PRO-1558
Placebo11

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Conjunctival Hyperemia (CH)

Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological. (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

,
Interventioneyes (Number)
NormalVery mildMildModerateSevere
Placebo0293680
PRO-1550392550

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Number of Eyes With Foreign Body Sensation (FBS)

Foreign body sensation will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent. (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

Interventioneyes (Count of Units)
PRO-15510
Placebo18

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Number of Eyes With Chemosis

In a normal eye there is no presence of chemosis (it is a sign of irritation of the eye, in which the outer covering of the eye can look like a large blister) its presence indicates a pathological state and it will be evaluated if the subjects present it. The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent. (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

Interventioneyes (Count of Units)
PRO-1550
Placebo0

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Intraocular Pressure (IOP)

the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg (NCT03521791)
Timeframe: will be evaluated at the end of the treatment at the final visit (day 21)

InterventionmmHg (Mean)
PRO-15512.45
Placebo13.08

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Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

Thickness of the cornea measured in microns, measured as the change from baseline (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops3.18
Standard of Care0.63

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Change From Baseline (Preoperative Exam) in Macular Thickness

Thickness of the macula measured in microns, recorded as the change from baseline. (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops4.91
Standard of Care1.30

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Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline (NCT03578276)
Timeframe: Month 1

InterventionmmHg (Mean)
LessDrops-0.33
Standard of Care-0.21

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McGill Pain Questionnaire (SF-MPQ) Scores at 24 Hours Post Injection

Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in participants undergoing intravitreal injections (IVI) of anti-VEGFs as measured by the SF-MPQ. The SF-MPQ questionnaire contains 15 sensory and affective descriptors each rated on a 0-3 scale where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. The total possible range of scores is 0-45 where the higher the score, the more intense the pain. (NCT04343222)
Timeframe: 24 hours post injection

Interventionscore on a scale (Mean)
Group A: Bromfenac Then Artificial Tears0
Group B: Artificial Tears Then Bromfenac0
Group C: Artificial Tears Then Artificial Tears0

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McGill Pain Questionnaire (SF-MPQ) Scores at 6 Hours Post Injection

Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in participants undergoing intravitreal injections (IVI) of anti-VEGFs as measured by the SF-MPQ. The SF-MPQ questionnaire contains 15 sensory and affective descriptors each rated on a 0-3 scale where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. The total possible range of scores is 0-45 where the higher the score, the more intense the pain. (NCT04343222)
Timeframe: 6 hours post injection

Interventionscore on a scale (Mean)
Group A: Bromfenac Then Artificial Tears0.50
Group B: Artificial Tears Then Bromfenac0.13
Group C: Artificial Tears Then Artificial Tears0.13

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Wong-Baker FACES Pain Scale Scores at 24 Hours Post Injection

"Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in patients undergoing intravitreal injections of anti-VEGFs as measured by the Wong-Baker FACES pain scale. This scale is compromised of drawings of faces that appear to be experiencing increasing pain, from which the participant chooses their current level of pain. Scoring is defined on the scale as, Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain." (NCT04343222)
Timeframe: 24 hours post injection

Interventionscore on a scale (Mean)
Group A: Bromfenac Then Artificial Tears0
Group B: Artificial Tears Then Bromfenac0
Group C: Artificial Tears Then Artificial Tears0

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Wong-Baker FACES Pain Scale Scores at 6 Hours Post Injection

"Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in patients undergoing intravitreal injections of anti-VEGFs as measured by the Wong-Baker FACES pain scale. This scale is compromised of drawings of faces that appear to be experiencing increasing pain, from which the participant chooses their current level of pain. Scoring is defined on the scale as, Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain." (NCT04343222)
Timeframe: 6 hours post injection

Interventionscore on a scale (Mean)
Group A: Bromfenac Then Artificial Tears0.53
Group B: Artificial Tears Then Bromfenac0.07
Group C: Artificial Tears Then Artificial Tears0.13

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Wong-Baker FACES Pain Scale Scores at Baseline

"Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in patients undergoing intravitreal injections of anti-VEGFs as measured by the Wong-Baker FACES pain scale. This scale is compromised of drawings of faces that appear to be experiencing increasing pain, from which the participant chooses their current level of pain. Scoring is defined on the scale as, Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain." (NCT04343222)
Timeframe: Baseline

Interventionscore on a scale (Mean)
Group A: Bromfenac Then Artificial Tears0.75
Group B: Artificial Tears Then Bromfenac1.13
Group C: Artificial Tears Then Artificial Tears0.53

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McGill Pain Questionnaire (SF-MPQ) Scores at Baseline

Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in participants undergoing intravitreal injections (IVI) of anti-VEGFs as measured by the SF-MPQ. The SF-MPQ questionnaire contains 15 sensory and affective descriptors each rated on a 0-3 scale where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. The total possible range of scores is 0-45 where the higher the score, the more intense the pain. (NCT04343222)
Timeframe: Baseline

Interventionscore on a scale (Mean)
Group A: Bromfenac Then Artificial Tears0.62
Group B: Artificial Tears Then Bromfenac0.93
Group C: Artificial Tears Then Artificial Tears0.53

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