Page last updated: 2024-12-08

nepafenac

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

nepafenac: amide analog of amfenac; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

nepafenac : A monocarboxylic acid amide that is amfenac in which the carboxylic acid group has been converted into the corresponding carboxamide. It is a prodrug for amfenac, used in eye drops to treat pain and inflammation following cataract surgery. [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 CID151075
CHEMBL ID1021
CHEBI ID75922
SCHEMBL ID93835
MeSH IDM0370991

Synonyms (86)

Synonym
AC-6949
CHEMBL1021
chebi:75922 ,
ahr-9434
al-6515
HY-17357
AB01274763-01
78281-72-8
nevanac (tn)
D05143
nepafenac (jan/usan/inn)
nepafenac
benzeneacetamide, 2-amino-3-benzoyl-
2-amino-3-benzoylbenzeneacetamide
nevanac
ahr 9434
2-(2-amino-3-benzoylphenyl)acetamide
nepafenac [usan]
al 6515
DB06802
AKOS005146108
A26218
2-(2-amino-3-benzoyl-phenyl)acetamide
NCGC00185741-01
nepafenac [usan:inn:ban:jan]
ilevro
unii-0j9l7j6v8c
0j9l7j6v8c ,
dtxcid7028564
tox21_112985
cas-78281-72-8
dtxsid0048638 ,
2-amino-3-benzoyl-phenylacetamide
QEFAQIPZVLVERP-UHFFFAOYSA-N
2-[2-amino-3-(benzoyl)phenyl]acetamide
N0932
MLS004774140
amfenac amide
MLS003915618
smr002529588
FT-0603701
nepafenac [mi]
nepafenac [vandf]
nepafenac [mart.]
nepafenac [jan]
nepafenac [usp-rs]
nepafenac [inn]
nepafenac [who-dd]
nepafenac [ema epar]
nepafenac [orange book]
CS-0899
S1255
nepafenacum
nepafenaco
gtpl7564
SCHEMBL93835
MLS006010644
tox21_112985_1
NCGC00185741-02
AB01274763_02
mfcd08067732
2-[2-amino-3-(phenylcarbonyl)phenyl]acetamide
STL451069
J-507774
EX-A1350
sr-01000931908
SR-01000931908-2
HMS3654P07
nepafenac, >=98% (hplc)
SW219197-1
BCP21333
AS-19176
Q684379
ahr 9434;al 6515
AMY10899
BRD-K04112579-001-02-1
bdbm50228731
HMS3884E07
CCG-267004
A890381
2-amino-3-benzoylbenzeneacetamide;nepafenac
WZB81453
EN300-7418512
s01bc10
nepafenac (mart.)
nepafenac (usp-rs)

Research Excerpts

Overview

Nepafenac is an innovative non-steroidal anti-inflammatory drug used in ophthalmology for the prevention of macular edema after cataract surgery. It is a potent NSAID that rapidly penetrates the eye following topical ocular administration.

ExcerptReferenceRelevance
"Nepafenac is a highly effective NSAID used for treating postoperative ocular inflammation and pain after cataract surgery and its advantage over conventional topical NSAIDs has been proved many times. "( Cyclodextrin-enabled nepafenac eye drops with improved absorption open a new therapeutic window.
Balogh, GT; Budai-Szűcs, M; Csorba, A; Facskó, R; Gyarmati, B; Katona, G; Nagy, ZZ; Szente, L; Vincze, A; Zelkó, R, 2023
)
2.67
"Nepafenac is an innovative non-steroidal anti-inflammatory drug used in ophthalmology for the prevention of macular edema after cataract surgery. "( The opinion of the Expert Group of the Polish Society of Ophthalmology on using nepafenac in the prevention of postoperative macular edema after cataract surgery in diabetic patients.
Bakunowicz-Łazarczyk, A; Gosławski, W; Grabska-Liberek, I; Jurowski, P; Karska-Basta, I; Kęcik, D; Lubiński, W; Malukiewicz, G; Mrukwa-Kominek, E; Omulecki, W; Pietruszyńska, M; Romaniuk, W; Romanowska-Dixon, B; Stafiej, J; Szaflik, JP,
)
1.8
"Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID), currently only available as 0.1% ophthalmic suspension (Nevanac®). "( Improved Ocular Delivery of Nepafenac by Cyclodextrin Complexation.
Abarca, EM; Grant, M; Jayachandra Babu, R; Shelley, H; Smith, FT, 2018
)
2.22
"Nepafenac is a water-insoluble nonsteroidal antiinflammatory drug that is available as an ophthalmic suspension (Nevanac®). "( In Situ Gel Formulation for Enhanced Ocular Delivery of Nepafenac.
Abarca, EM; Babu, RJ; Duran, SH; Rodriguez-Galarza, RM; Shelley, H, 2018
)
2.17
"Nepafenac is a potent NSAID that rapidly penetrates the eye following topical ocular administration. "( The effects of nepafenac and amfenac on retinal angiogenesis.
Bingaman, DP; Clark, ML; Penn, JS; Yang, R; Yanni, SE, 2010
)
2.16

Effects

Nepafenac 0.1% has been shown to be effective in suppressing inflammation after cataract surgery in uveitic eyes as well as in healthy eyes.

ExcerptReferenceRelevance
"Nepafenac has been shown additive effect on pupil dilation in diabetic patients before cataract surgery."( Additive Effect of Topical Nepafenac on Mydriasis in Patients With Diabetes Mellitus.
Inanc, M; Kiziltoprak, H; Koc, M; Ozulken, K; Tekin, K; Yetkin, E, 2020
)
2.3
"Nepafenac 0.1% has been shown to be effective in suppressing inflammation after cataract surgery in uveitic eyes as well as in healthy eyes. "( Comparison of the efficacy of nepafenac 0.1% in quiescent Behçet's uveitis and non-uveitic healthy patients after phacoemulsification surgery.
Işık, MU; Yalçındağ, NF, 2020
)
2.29

Actions

Nepafenac and amfenac inhibit OIR more effectively than the commercially available topical and injectable NSAIDs used in this study. The NepafenAC group had lower mean aqueous cells, flare, and cells plus flare scores at all visits.

ExcerptReferenceRelevance
"Nepafenac and amfenac inhibit OIR more effectively than the commercially available topical and injectable NSAIDs used in this study. "( The effects of nepafenac and amfenac on retinal angiogenesis.
Bingaman, DP; Clark, ML; Penn, JS; Yang, R; Yanni, SE, 2010
)
2.16
"Nepafenac's ability to inhibit PG synthesis in the retina/choroid following topical administration indicates the drug also targets suppression of PG synthesis in the posterior segment. "( Ocular permeation and inhibition of retinal inflammation: an examination of data and expert opinion on the clinical utility of nepafenac.
Kim, T; Lindstrom, R, 2006
)
1.98
"The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P<.0001)."( Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular inflammation associated with cataract surgery.
Holland, EJ; Lane, SS; Lehmann, RP; Modi, SS, 2007
)
2.26

Treatment

Nepafenac treatment significantly reduced retinal NV in OIR; ketorolac and diclofenac had no effect. NepafenAc 0.1% treatment may offer greater comfort upon instillation in patients who have undergone PRK.

ExcerptReferenceRelevance
"Nepafenac treatment significantly increased the proportion of patients with resolved ocular inflammation, compared to placebo, beginning on day 1 for TID dosing ( p ( Nepafenac dosing frequency for ocular pain and inflammation associated with cataract surgery.
Cavanagh, HD; Maxwell, WA; Meuse, PA; Reiser, HJ; Sager, DP; Stewart, RH; Walters, TR, 2008
)
2.51
"Nepafenac treatment significantly reduced retinal NV in OIR; ketorolac and diclofenac had no effect."( The effects of nepafenac and amfenac on retinal angiogenesis.
Bingaman, DP; Clark, ML; Penn, JS; Yang, R; Yanni, SE, 2010
)
1.43
"Nepafenac 0.1% treatment may offer greater comfort upon instillation in patients who have undergone PRK."( Double-masked study of the effects of nepafenac 0.1% and ketorolac 0.4% on corneal epithelial wound healing and pain after photorefractive keratectomy.
Donnenfeld, ED; Durrie, DS; Holland, EJ; Raizman, MB,
)
1.12
"Treatment with nepafenac ophthalmic suspension 0.1% significantly reduced postoperative pain compared with placebo after pterygium surgery."( Effect of nepafenac eye drops on pain associated with pterygium surgery.
Bukus, A; Demir, LS; Goktas, S; Ozcimen, M; Sakarya, R; Sakarya, Y; Yener, HI, 2015
)
1.17
"Eyes treated with nepafenac healed at a slower rate than eyes treated with ketorolac in 57% of patients."( Double-masked comparison of ketorolac tromethamine 0.4% versus nepafenac sodium 0.1% for postoperative healing rates and pain control in eyes undergoing surface ablation.
McDonald, M; Trattler, W, 2007
)
0.9
"Eyes treated with nepafenac 0.1% or ketorolac 0.4% achieved complete reepithelialization significantly faster than those treated with bromfenac 0.09%."( Effects of nonsteroidal ophthalmic drops on epithelial healing and pain in patients undergoing bilateral photorefractive keratectomy (PRK).
Boghossian, AJ; Durrie, DS; Kennard, MG,
)
0.45
"Treatment with nepafenac 0.1% significantly reduced postoperative pain immediately following surgery and had no significant adverse effect on time to reepithelialization compared to placebo."( Effects of topical nepafenac on corneal epithelial healing time and postoperative pain after PRK: a bilateral, prospective, randomized, masked trial.
Caldwell, M; Reilly, C, 2008
)
1.03

Toxicity

ExcerptReferenceRelevance
" Adverse events were documented when reported by the patients themselves, and when study personnel asked about specific events."( Comparison of the analgesic efficacy and safety of nepafenac ophthalmic suspension compared with diclofenac ophthalmic solution for ocular pain and photophobia after excimer laser surgery: a phase II, randomized, double-masked trial.
Colin, J; Paquette, B, 2006
)
0.59
" Adverse events were infrequent, and no serious adverse events occurred."( Comparison of the analgesic efficacy and safety of nepafenac ophthalmic suspension compared with diclofenac ophthalmic solution for ocular pain and photophobia after excimer laser surgery: a phase II, randomized, double-masked trial.
Colin, J; Paquette, B, 2006
)
0.59
" Extensive studies to detect adverse response ranged from a gross examination of eyes under slit lamp biomicroscope, fluorescein dye test, Schirmer tear test, test for corneal sensitivity, intraocular pressure measurement (IOP), specular microscopy, electroretinography(ERG), and histopathological examination of intraocular tissues."( Intracameral Use of Nepafenac: Safety and Efficacy Study.
Bhattacharjee, A; Ghosh, T; Hazra, S; Jha, R; Konar, A; Kumar, V; Sur, V, 2018
)
0.8
" Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group."( Safety and efficacy of nepafenac punctal plug delivery system in controlling postoperative ocular pain and inflammation after cataract surgery.
Donnenfeld, ED; Holland, EJ; Solomon, KD, 2021
)
0.93
"The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery."( Safety and efficacy of nepafenac punctal plug delivery system in controlling postoperative ocular pain and inflammation after cataract surgery.
Donnenfeld, ED; Holland, EJ; Solomon, KD, 2021
)
0.93

Pharmacokinetics

ExcerptReferenceRelevance
" 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
)
0.95

Compound-Compound Interactions

ExcerptReferenceRelevance
"To investigate the incidence and outcomes of cystoid macular edema (CME) after Descemet membrane endothelial keratoplasty (DMEK) alone and DMEK combined with cataract surgery (DMEK triple)."( Incidence and Outcomes of Cystoid Macular Edema after Descemet Membrane Endothelial Keratoplasty (DMEK) and DMEK Combined with Cataract Surgery.
Bae, SS; Ching, G; Covello, AT; Holland, S; Iovieno, A; McCarthy, M; Ritenour, R; Yeung, SN, 2021
)
0.62

Bioavailability

ExcerptReferenceRelevance
"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
)
2.03
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

Nepafenac treatment significantly increased the proportion of patients with resolved ocular inflammation, compared to placebo, beginning on day 1 for TID dosing.

ExcerptRelevanceReference
"1% was dosed topically once (QD), twice (BID), or three-times (TID) daily to assess the resolution of ocular pain and anterior-segment inflammation following cataract surgery."( Nepafenac dosing frequency for ocular pain and inflammation associated with cataract surgery.
Cavanagh, HD; Maxwell, WA; Meuse, PA; Reiser, HJ; Sager, DP; Stewart, RH; Walters, TR, 2008
)
1.79
"1% was well tolerated and effectively resolved ocular inflammation and increased the incidence of ocular pain-free patients following cataract surgery when dosed QD, BID, or TID."( Nepafenac dosing frequency for ocular pain and inflammation associated with cataract surgery.
Cavanagh, HD; Maxwell, WA; Meuse, PA; Reiser, HJ; Sager, DP; Stewart, RH; Walters, TR, 2008
)
1.79
"We report a case of sterile ulceration after photorefractive keratectomy surgery, which we believe was caused by frequent postoperative dosing of nepafenac."( Nepafenac-associated bilateral corneal melt after photorefractive keratectomy.
Feiz, V; Kurz, CJ; Mamalis, N; Moshirfar, M; Oberg, TJ, 2009
)
2
" 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
)
0.83
"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
)
0.6
" 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
)
0.6
"1% and dosed 4 times a day starting 1 day before surgery and continuing for 4 weeks."( Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification.
Almeida, DR; Bakar, SN; El-Defrawy, SR; Khan, Z; Rahim, K; Urton, T; Xing, L, 2012
)
0.75
"3% product may have some advantages over its predecessor: it is dosed once rather than thrice daily, which may increase patient adherence and improve outcomes."( Nepafenac: an ophthalmic nonsteroidal antiinflammatory drug for pain after cataract surgery.
Jones, BM; Neville, MW, 2013
)
1.83
"The aim of the present study was to develop and validate an analytical method for the estimation of nepafenac as a raw material as well as in dosage form (suspension) by using reverse phase high performance liquid chromatographic (RP-HPLC)."( Development and validation of HPLC analytical method for nepafenac in ophthalmic dosage form (suspension).
Akram, M; Aziz, A; Ramesh, V; Sarheed, OA; Usman, S, 2014
)
0.86
" Locally-distributed compound concentrations were determined as the difference in levels between dosed and undosed eyes."( Distribution of topical ocular nepafenac and its active metabolite amfenac to the posterior segment of the eye.
Chastain, JE; Chemuturi, NV; Curtis, MA; Dahlin, DC; Gadd, ME; Kapin, MA; Markwardt, KL; Sanders, ME, 2016
)
0.72
"3% in a once daily dosage regarding pain and healing after photorefractive keratectomy (PRK)."( Nepafenac Ophthalmic Suspension 0.3% for the Management of Ocular Pain After Photorefractive Keratectomy.
Chronopoulou, KG; Kontadakis, GA; Kymionis, GD; Tabibian, D; Tsopouridou, R, 2018
)
1.92
" However, Nevanac® is a suspension eye drop, which clearly lacks patient compliance causing irritation, blurred vision, foreign body sensation along with problematic dosage due to its sticky, inhomogeneous consistence."( Cyclodextrin-enabled nepafenac eye drops with improved absorption open a new therapeutic window.
Balogh, GT; Budai-Szűcs, M; Csorba, A; Facskó, R; Gyarmati, B; Katona, G; Nagy, ZZ; Szente, L; Vincze, A; Zelkó, R, 2023
)
1.23
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (5)

RoleDescription
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
cyclooxygenase 2 inhibitorA cyclooxygenase inhibitor that interferes with the action of cyclooxygenase 2.
cyclooxygenase 1 inhibitorA cyclooxygenase inhibitor that interferes with the action of cyclooxygenase 1.
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 (1)

ClassDescription
monocarboxylic acid amideA carboxamide derived from a monocarboxylic acid.
[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
Nepafenac Action Pathway2967

Protein Targets (17)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
RAR-related orphan receptor gammaMus musculus (house mouse)Potency18.95860.006038.004119,952.5996AID1159521; AID1159523
TDP1 proteinHomo sapiens (human)Potency33.49830.000811.382244.6684AID686978
AR proteinHomo sapiens (human)Potency21.31380.000221.22318,912.5098AID743036
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency13.33320.001022.650876.6163AID1224838; AID1224893
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency27.54040.01237.983543.2770AID1645841
EWS/FLI fusion proteinHomo sapiens (human)Potency20.20080.001310.157742.8575AID1259252; AID1259253; AID1259256
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency7.09010.001530.607315,848.9004AID1224848; AID1224849
estrogen nuclear receptor alphaHomo sapiens (human)Potency1.69300.000229.305416,493.5996AID743069
GVesicular stomatitis virusPotency17.37680.01238.964839.8107AID1645842
aryl hydrocarbon receptorHomo sapiens (human)Potency16.78550.000723.06741,258.9301AID743085
Interferon betaHomo sapiens (human)Potency17.37680.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency17.37680.01238.964839.8107AID1645842
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency35.48130.009610.525035.4813AID1479145
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency17.37680.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency17.37680.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Prostaglandin G/H synthase 2 Rattus norvegicus (Norway rat)IC50 (µMol)100.00000.00291.786810.0000AID161308
Prostaglandin G/H synthase 1 Rattus norvegicus (Norway rat)IC50 (µMol)100.00000.00291.823210.0000AID161308
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (45)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (18)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (23)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (38)

Assay IDTitleYearJournalArticle
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID188026Pharmacological potency relative to indomethacin for prodrug candidate by adjuvant-induced arthritis assay1990Journal of medicinal chemistry, Aug, Volume: 33, Issue:8
Antiinflammatory agents. 4. Syntheses and biological evaluation of potential prodrugs of 2-amino-3-benzoylbenzeneacetic acid and 2-amino-3-(4-chlorobenzoyl)benzeneacetic acid.
AID171871Antiinflammatory activity was tested in Pleural effusion rate assay and the percent change in average volume of pleural fluid at the dose of 100 mg/kg1990Journal of medicinal chemistry, Aug, Volume: 33, Issue:8
Antiinflammatory agents. 4. Syntheses and biological evaluation of potential prodrugs of 2-amino-3-benzoylbenzeneacetic acid and 2-amino-3-(4-chlorobenzoyl)benzeneacetic acid.
AID171870Antiinflammatory activity was tested in Pleural effusion rate assay and the percent change in average volume of pleural fluid at indomethacin dose of 4.0 mg/kg. 1990Journal of medicinal chemistry, Aug, Volume: 33, Issue:8
Antiinflammatory agents. 4. Syntheses and biological evaluation of potential prodrugs of 2-amino-3-benzoylbenzeneacetic acid and 2-amino-3-(4-chlorobenzoyl)benzeneacetic acid.
AID171873Antiinflammatory activity was tested in pleural effusion rate assay and the percent change in average volume of pleural fluid at the dose of 4.0 mg/kg1990Journal of medicinal chemistry, Aug, Volume: 33, Issue:8
Antiinflammatory agents. 4. Syntheses and biological evaluation of potential prodrugs of 2-amino-3-benzoylbenzeneacetic acid and 2-amino-3-(4-chlorobenzoyl)benzeneacetic acid.
AID161308Inhibitory activity against Prostaglandin G/H synthase1990Journal of medicinal chemistry, Aug, Volume: 33, Issue:8
Antiinflammatory agents. 4. Syntheses and biological evaluation of potential prodrugs of 2-amino-3-benzoylbenzeneacetic acid and 2-amino-3-(4-chlorobenzoyl)benzeneacetic acid.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (144)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's1 (0.69)18.2507
2000's33 (22.92)29.6817
2010's77 (53.47)24.3611
2020's33 (22.92)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 87.42

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 Index87.42 (24.57)
Research Supply Index5.39 (2.92)
Research Growth Index5.98 (4.65)
Search Engine Demand Index153.22 (26.88)
Search Engine Supply Index2.01 (0.95)

This Compound (87.42)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials61 (38.85%)5.53%
Reviews9 (5.73%)6.00%
Case Studies14 (8.92%)4.05%
Observational3 (1.91%)0.25%
Other70 (44.59%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (52)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial [NCT03918590]Phase 460 participants (Actual)Interventional2018-12-03Enrolling by invitation
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery [NCT03851172]Phase 275 participants (Anticipated)Interventional2019-03-01Not yet recruiting
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
Evaluation on Efficacy of Topical Nepafenac as Supplement Therapy in the Treatment of Diabetic Macular Edema [NCT02443012]Phase 447 participants (Actual)Interventional2013-03-31Completed
Comparison of Ketorolac Tromethamine 0.4% and Nepafenac 0.1% for the Prevention of Cystoid Macular Edema After Phacoemulsification: Prospective Randomized Double-masked Study [NCT02084576]Phase 440 participants (Actual)Interventional2013-08-31Completed
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% Compared to Nepafenac Ophthalmic Suspension 0.1% and Vehicle for Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery [NCT01318499]Phase 21,342 participants (Actual)Interventional2011-03-31Completed
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
A Randomized Clinical Two-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Postoperative Topical NSAIDs and Steroids to Only Postoperative Topical Steroids in Patients Undergoing Corneal Endothelial Transplantations ( [NCT05072262]Phase 4300 participants (Anticipated)Interventional2022-11-25Recruiting
A Randomized Clinical Three-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Preoperative and Postoperative Topical NSAIDs to Only Postoperative Topical NSAIDs to Postoperative Topical NSAIDs and Steroids in Patients [NCT05331690]Phase 4500 participants (Anticipated)Interventional2022-11-25Recruiting
[NCT00818844]Phase 440 participants (Actual)Interventional2009-01-31Completed
[NCT00939276]Phase 3175 participants (Actual)Interventional2009-08-31Terminated(stopped due to Patient recruitment difficulties)
[NCT02506348]30 participants (Anticipated)Interventional2015-07-31Recruiting
A Randomized, Multicenter, Double Masked, Placebo Controlled, Parallel Group, Bioequivalence Study to Evaluate the Clinical Equivalence and Safety of Nepafenac 0.3% Ophthalmic Suspension (Manufactured by Indoco Remedies Ltd. for Actavis LLC) With IlevroTM [NCT03499873]Phase 3448 participants (Actual)Interventional2018-03-28Completed
Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation [NCT00801905]Phase 250 participants (Anticipated)Interventional2008-08-31Recruiting
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
Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5% [NCT02752646]200 participants (Actual)Interventional2016-04-30Completed
Phase 4 Study of Topical NSAID for Ophthalmologic Use: Pain Measurement After First Drop. [NCT00869219]Phase 440 participants (Anticipated)Interventional2009-03-31Recruiting
Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema [NCT00900887]Phase 284 participants (Actual)Interventional2008-04-30Completed
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients [NCT00782717]Phase 2263 participants (Actual)Interventional2008-11-30Completed
Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies [NCT00865540]Phase 430 participants (Actual)Interventional2009-03-31Active, not recruiting
Analgesic Effect Of Topical Nepafenac 0.1% On Pain Related To Intravitreal Injections: A Randomized Crossover Study [NCT02821390]55 participants (Actual)Interventional2016-06-30Completed
Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK) [NCT01395069]Phase 4162 participants (Actual)Interventional2010-02-28Completed
A Randomized Parallel, Masked to Evaluate the Efficacy of Triamcinolone Associated With Nepafenac (Nevanac) Compared With Intravitreal Injection of Triamcinolone for Treatment of Clinically Significant Diabetic Macular Edema [NCT00780780]Phase 340 participants (Actual)Interventional2007-07-31Completed
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial [NCT01939691]Phase 49 participants (Actual)Interventional2018-09-12Terminated(stopped due to Difficulty enrolling)
Effect of Nepafenac Eye Drops on Intraocular Pressure - a Randomized Prospective Study [NCT01995890]Phase 4327 participants (Actual)Interventional2012-12-31Completed
Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery [NCT01109173]Phase 32,120 participants (Actual)Interventional2010-06-30Completed
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
A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery [NCT00332774]Phase 3149 participants (Actual)Interventional2006-02-28Completed
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification [NCT01021761]Phase 4126 participants (Actual)Interventional2009-10-31Completed
Double Masked Evaluation of Acular LS Versus Nevanac for Postoperative Pain Control in Eyes Undergoing PRK [NCT00347204]Phase 440 participants Interventional2006-01-31Completed
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy [NCT02955641]100 participants (Anticipated)Interventional2016-11-01Recruiting
Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections, a Triple Arm Study [NCT03406689]99 participants (Actual)Interventional2017-09-01Completed
Influence of Combined Eplerenone , Intravitreal Aflibercept and Topical Nepafenac Therapy on Serous Foveal Detachment in Central Serous Chorioretinopathy (CSCR) [NCT05847049]16 participants (Actual)Observational2023-02-28Completed
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study [NCT00405730]Phase 3227 participants (Actual)Interventional2005-11-30Completed
[NCT00407017]Phase 40 participants InterventionalCompleted
Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen [NCT02515045]Phase 459 participants (Actual)Interventional2015-01-31Completed
A Phase II Evaluation of Topical Non-steroidal Anti-inflammatories in Eyes With Non Central Involved Diabetic Macular Edema [NCT01331005]Phase 2125 participants (Actual)Interventional2011-05-31Completed
Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery [NCT00333255]Phase 3267 participants (Actual)Interventional2005-09-30Completed
A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study [NCT00330798]Phase 440 participants (Actual)Interventional2006-02-28Completed
Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery [NCT00348582]Phase 40 participants InterventionalCompleted
Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients [NCT01657266]Phase 2160 participants (Actual)Interventional2013-12-31Completed
Clinical Study Evaluating Safety and Efficacy of a Nepafenac Punctal Plug Delivery System (N-PPDS) Compared With Placebo Punctal Plug Delivery System (p-PPDS) in Controlling Post-Operative Ocular Pain and Inflammation After Routine Unilateral Cataract Sur [NCT03496467]Phase 256 participants (Actual)Interventional2018-03-05Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01872611]Phase 3819 participants (Actual)Interventional2013-06-30Completed
Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo [NCT03025945]662 participants (Actual)Interventional2013-10-31Completed
[NCT00377546]Phase 40 participants InterventionalCompleted
Corneal Dystrophies Caused by SLC4A11 Mutation: A Promising New Paradigm Shift in Therapy Using an Ophthalmic Nonsteroidal Anti-Inflammatory Eye Drops [NCT04843839]Phase 230 participants (Anticipated)Interventional2020-12-15Recruiting
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01853072]Phase 3881 participants (Actual)Interventional2013-06-30Completed
Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery [NCT00494494]Phase 482 participants (Actual)Interventional2007-06-30Completed
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
A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification [NCT01001806]Phase 4126 participants (Actual)Interventional2009-10-31Completed
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
Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery in Adult Chinese Subjects [NCT01426854]Phase 3260 participants (Actual)Interventional2011-07-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00494494 (5) [back to overview]Foveal Thickness
NCT00494494 (5) [back to overview]Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)
NCT00494494 (5) [back to overview]Pre-operative Best Corrected Visual Acuity (BCVA)
NCT00494494 (5) [back to overview]Post-operative Best Corrected Visual Acuity (BCVA)
NCT00494494 (5) [back to overview]Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)
NCT00782717 (2) [back to overview]Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
NCT00782717 (2) [back to overview]Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
NCT01001806 (1) [back to overview]Peak Aqueous Penetration
NCT01021761 (1) [back to overview]Aqueous PGE2 Inhibition
NCT01109173 (2) [back to overview]Percentage of Patients Cured at Day 14
NCT01109173 (2) [back to overview]Percentage of Patients Pain-Free at Day 14
NCT01310127 (4) [back to overview]Summed Ocular Inflammation Score (SOIS)
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
NCT01318499 (5) [back to overview]Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%
NCT01318499 (5) [back to overview]Cumulative Percent Clinical Success by Visit
NCT01318499 (5) [back to overview]Cumulative Percentage of Patients Cured by Visit
NCT01318499 (5) [back to overview]Cumulative Percentage of Patients Pain Free by Visit
NCT01318499 (5) [back to overview]Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%
NCT01331005 (3) [back to overview]Change in OCT Central Subfield Thickness
NCT01331005 (3) [back to overview]Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3
NCT01331005 (3) [back to overview]Mean Change in Visual Acuity
NCT01426854 (2) [back to overview]Proportion of Subjects Who Were Pain-Free at All Postoperative Visits
NCT01426854 (2) [back to overview]Proportion of Subjects With Clinical Cure at Day 14
NCT01657266 (8) [back to overview]Percentage of Cellularity in Anterior Chamber
NCT01657266 (8) [back to overview]Intraocular Pressure
NCT01657266 (8) [back to overview]Flare in Anterior Chamber
NCT01657266 (8) [back to overview]Epithelial Defects Detected With Green Lissamine
NCT01657266 (8) [back to overview]Epithelial Defects Detected With Fluorescein
NCT01657266 (8) [back to overview]Percentage of Patients Without Ocular Pain
NCT01657266 (8) [back to overview]Mean Aqueous Concentration of Intervention Drug
NCT01657266 (8) [back to overview]Retinal Thickness
NCT01847638 (3) [back to overview]Retinal Thickness
NCT01847638 (3) [back to overview]Treatment of Inflammation Associated With Cataract Surgery
NCT01847638 (3) [back to overview]Visual Acuity
NCT01853072 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01853072 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01853072 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01853072 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01872611 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01872611 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01872611 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01872611 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT03025945 (1) [back to overview]Post-operative Clinical Findings of Cystoid Macular Edema

Foveal Thickness

difference in mean pre-post changes by the two treatment groups (NCT00494494)
Timeframe: baseline and 8 weeks

Interventionmicrons (Mean)
Standard Treatment-2.0
Nepafenac4.7

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Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)

The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness) (NCT00494494)
Timeframe: baseline and 8 weeks

Interventionmicrons (Mean)
Standard Treatment2.78
Nepafenac5.6

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Pre-operative Best Corrected Visual Acuity (BCVA)

Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity. (NCT00494494)
Timeframe: baseline

Interventionletters (Mean)
Standard Treatment38.48
Nepafenac40.49

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Post-operative Best Corrected Visual Acuity (BCVA)

The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity. (NCT00494494)
Timeframe: baseline and 8 weeks

Interventionletters (Mean)
Standard Treatment54.46
Nepafenac55.49

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Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)

(NCT00494494)
Timeframe: baseline and 8 weeks

Interventionmicrons (Mean)
Standard Treatment0.05
Nepafenac0.10

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Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).

BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. (NCT00782717)
Timeframe: From Day 7 to Day 90 (or Early Exit)

InterventionPercentage of patients (Number)
NEVANAC6
Nepafenac Vehicle12

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Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery

Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). (NCT00782717)
Timeframe: 3 Months

InterventionPercentage of patients (Number)
NEVANAC3
Nepafenac Vehicle17

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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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Percentage of Patients Cured at Day 14

Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare. (NCT01109173)
Timeframe: Day 14

Interventionpercentage of participants (Number)
Nepafenac 0.3%68.4
NEVANAC70.0
Nepafenac Vehicle 0.3%34.0
NEVANAC Vehicle35.6

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Percentage of Patients Pain-Free at Day 14

Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain. (NCT01109173)
Timeframe: Day 14

Interventionpercentage of participants (Number)
Nepafenac 0.3%91
NEVANAC90.9
Nepafenac Vehicle 0.3%49.7
NEVANAC Vehicle56.1

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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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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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Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%

Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. (NCT01318499)
Timeframe: Day 7 postoperative

InterventionPercentage of patients (Number)
Nepafenac 0.3%31.3
Nepafenac 0.1%30.8

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Cumulative Percent Clinical Success by Visit

Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Clinical success occurred when the cell grade was ≤ 1 (0-5 cells) and flare grade was = 0. To be included in the cumulative summary at a visit, a patient must have been declared a clinical success at the visit and remained a clinical success at all subsequent visits. (NCT01318499)
Timeframe: Day 1, Day 3, Day 7, Day 14

,,
InterventionPercentage of patients (Number)
Day 1Day 3Day 7Day 14
Nepafenac 0.1%15.035.962.581.3
Nepafenac 0.3%18.943.971.984.8
Nepafenac Vehicle 0.3%12.318.729.437.7

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Cumulative Percentage of Patients Cured by Visit

Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits. (NCT01318499)
Timeframe: Day 1, Day 3, Day 7, Day 14

,,
InterventionPercentage of patients (Number)
Day 1Day 3Day 7Day 14
Nepafenac 0.1%1.87.130.865.3
Nepafenac 0.3%0.46.431.364.6
Nepafenac 0.3% Vehicle0.43.210.325.0

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Cumulative Percentage of Patients Pain Free by Visit

Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits. (NCT01318499)
Timeframe: Day 1, Day 3, Day 7, Day 14

,,
InterventionPercentage of patients (Number)
Day 1Day 3Day 7Day 14
Nepafenac 0.1%61.975.983.089.0
Nepafenac 0.3%65.277.384.889.1
Nepafenac 0.3% Vehicle17.525.831.740.1

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Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%

Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. (NCT01318499)
Timeframe: Day 14 postoperative

InterventionPercentage of patients (Number)
Nepafenac 0.3%64.6
Nepafenac Vehicle 0.3%25.0

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Change in OCT Central Subfield Thickness

95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year. (NCT01331005)
Timeframe: baseline to 12 months

Interventionmicrons (Mean)
Placebo7
Nepafenac 0.1% Drops9

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Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3

(NCT01331005)
Timeframe: From Baseline to 12 months

Interventionmm3 (Mean)
Placebo0.02
Nepafenac 0.1% Drops-0.03

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Mean Change in Visual Acuity

The 95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for diabetic macular edema(DME) before 1 year, visual acuity and optical coherence tomography (OCT) measurements obtained at time of failure will be used instead of measurements at 1 year. (NCT01331005)
Timeframe: baseline to 12 months

InterventionLetter Score (Mean)
Placebo-0.3
Nepafenac 0.1% Drops0.2

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Proportion of Subjects Who Were Pain-Free at All Postoperative Visits

Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage. (NCT01426854)
Timeframe: Up to Day 14

InterventionPercentage of subjects (Number)
Nepafenac71.3
Placebo40.2

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Proportion of Subjects With Clinical Cure at Day 14

Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage. (NCT01426854)
Timeframe: Day 14 postoperative

InterventionPercentage of subjects (Number)
Nepafenac80.3
Placebo39.3

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Percentage of Cellularity in Anterior Chamber

Change from Percentage of Cellularity in anterior chamber after 30 days of treatment. (NCT01657266)
Timeframe: day 30

,
InterventionPercentage of Cellularity (Number)
Day 1Day 30
Nevanac64.30
PRO-15564.20

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Intraocular Pressure

Change from Baseline in the intraocular pressure after 30 days of treatment (NCT01657266)
Timeframe: day 30

,
InterventionmmHg (Mean)
Day 0Day 1Day 7Day 15Day 30
Nevanac14.2315.8314.5413.9113.77
PRO-15514.0714.6614.1313.8114.10

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Flare in Anterior Chamber

Percentage of Participants with flare in anterior chamber after 30 days of treatment (NCT01657266)
Timeframe: day 30

,
InterventionPercentage of Participants with flare (Number)
Day 1Day 30
Nevanac31.50
PRO-15531.40

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Epithelial Defects Detected With Green Lissamine

the percentage of patients presenting epithelial defects evaluated with green lysine will be reported (NCT01657266)
Timeframe: measurements will be made at days 1, 5, 7 and 30

,
Interventionpercentage of patients with defects (Number)
Day 1Day 7Day 15Day 30
Nevanac8667.357.428.2
PRO-15562.541.421.614.8

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Epithelial Defects Detected With Fluorescein

The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated (NCT01657266)
Timeframe: measurements will be made at days 1, 5, 7 and 30

,
Interventionpercentage of patients with defects (Number)
Day 1Day 7Day 15Day 30
Nevanac78.564.436.18.5
PRO-15554.432.515.66

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Percentage of Patients Without Ocular Pain

percentage of patients without pain, would be measured using the Visual Analog Pain Scale (NCT01657266)
Timeframe: day 30

,
Interventionpercentage of patients (Number)
Day 1Day 30
Nevanac5.71.6
PRO-1556.11.5

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Mean Aqueous Concentration of Intervention Drug

a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification. (NCT01657266)
Timeframe: before surgery

Interventionng/mL (Mean)
PRO-155207.5
Nevanac314.4

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Retinal Thickness

Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery. (NCT01657266)
Timeframe: day 30 and 60

,
Interventionμm (Mean)
field A1 day 0field A1 day 30field A1 day 60
Nevanac250.87264.08260.13
PRO-155247.24252.06254.06

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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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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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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac2.3
Vehicle17.3

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac15.4
Vehicle27.3

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01853072)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac76.2
Vehicle64.7

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01853072)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac77.2
Vehicle67.7

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac9.1
Vehicle15.3

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac61.7
Vehicle43.0

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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac5.9
Vehicle14.3

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac18.7
Vehicle16.7

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01872611)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac68.9
Vehicle62.1

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01872611)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac65.4
Vehicle65.9

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac48.8
Vehicle50.5

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac10.7
Vehicle8.9

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

Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign. (NCT02515045)
Timeframe: Month 1.

InterventionmmHg (Mean)
TriMoxiVanc-0.5
TriMoxiVanc + Ilevro-1.03
Control-1.1

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Change From Baseline (Preoperative Exam) in Macular Thickness

Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease. (NCT02515045)
Timeframe: Month 1.

InterventionMicrons (Mean)
TriMoxiVanc12.34
TriMoxiVanc + Ilevro10.96
Control9.84

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

"Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.~An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery." (NCT02515045)
Timeframe: Month 1

InterventionMicrons (Mean)
TriMoxiVanc14.44
TriMoxiVanc + Ilevro5.94
Control4.47

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Post-operative Clinical Findings of Cystoid Macular Edema

post-operative macular volume (mm) (NCT03025945)
Timeframe: 6 weeks

Interventionmm (Mean)
Nepafenac 0.3%8.85
Saline Solution8.95

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