Page last updated: 2024-12-08

loteprednol etabonate

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Description

Loteprednol Etabonate: An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID444025
CHEMBL ID1200865
CHEBI ID31784
SCHEMBL ID23907
MeSH IDM0174971

Synonyms (87)

Synonym
HY-17358
AB00698349-07
idr-90102
hgp-1
idr-90103
loteprednol etabonate
lotemax
locort
p-5604
alrex
cddd-5604
loterox
chloromethyl 17alpha-[(ethoxycarbonyl)oxy]-11beta-hydroxy-3-oxoandrosta-1,4-diene-17beta-carboxylate
CHEBI:31784 ,
MLS001424221
smr000469178
D01689
loteprednol etabonate (jan/usan)
82034-46-6
lotemax (tn)
loteprednol etabonate opphthalmic suspension
chloromethyl 11beta,17-dihydroxy-3-oxoandrosta-1,4-diene-17beta-carboxylate, 17-(ethyl carbonate)
cddd 5604
chloromethyl 17-ethoxycarbonyloxy-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate
loteprednol etabonate [usan]
cehoac
hgp 1
androsta-1,4-diene-17-carboxylic acid, 17-((ethoxycarbonyl)oxy)-11-hydroxy-3-oxo-, chloromethyl ester, (11beta,17alpha)-
p 5604
HMS2051F16
CHEMBL1200865
kpi-121
AKOS005145741
chloromethyl (8s,9s,10r,11s,13s,14s,17r)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthrene-17-carboxylate
inveltys
unii-yeh1ez96k6
yeh1ez96k6 ,
loteprednol etabonate [usan:jan]
dtxcid0026468
dtxsid2046468 ,
cas-82034-46-6
tox21_112219
HMS2232J09
CCG-101041
loteprednol etabonate [mart.]
loteprednol etabonate [who-dd]
loteprednol etabonate [orange book]
zylet component loteprednol etabonate
eysuvis
cddd5604
loteprednol etabonate component of zylet
loteprednol etabonate [vandf]
loteprednol etabonate [jan]
loteprednol etabonate [mi]
androsta-1,4-diene-17-carboxylic acid, 17-((ethoxycarbonyl)oxy)-11-hydroxy-3-oxo-, chloromethyl ester, (11.beta.,17.alpha.)-
CS-0900
S1669
gtpl7085
AB00698349-05
NC00291
SCHEMBL23907
tox21_112219_1
NCGC00164594-02
loteprednoletabonate
AB00698349_08
chloromethyl 17 ethoxycarbonyloxy 11 hydroxy 3 oxoandrosta 1,4 diene 17 carboxylate
17-ethoxycarbonyloxy-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate, chloromethyl
etabonate, loteprednol
chloromethyl (1s,2r,10s,11s,14r,15s,17s)-14-[(ethoxycarbonyl)oxy]-17-hydroxy-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-diene-14-carboxylate
GS-3599
loteprednol etabonate, >=98% (hplc)
HMS3715N06
DMKSVUSAATWOCU-HROMYWEYSA-N
bdbm50248301
airex
Q3837481
DB14596
BCP28645
(11b,17a)-17-[(ethoxycarbonyl)oxy]-11-hydroxy-3-oxo-androsta-1,4-diene-17-carboxylic acid chloromethyl ester
EN300-19768286
chloromethyl (1r,3as,3bs,9ar,9bs,10s,11as)-1-[(ethoxycarbonyl)oxy]-10-hydroxy-9a,11a-dimethyl-7-oxo-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthrene-1-carboxylate
chloromethyl 17alpha-((ethoxycarbonyl)oxy)-11beta-hydroxy-3-oxoandrosta-1,4-diene-17beta-carboxylate
androsta-1,4-diene-17-carboxylic acid, 17-((ethoxycarbonyl)oxy)-11-hydroxy-3-oxo-, chloromethyl ester,(11beta,17alpha)-
loteprednol etabonate (mart.)
lotemax sm
chlorometyl 17alpha-((ethoxycarbonyl)oxy)-11beta-hydroxy-3-oxoandrosla-1,4-diene-17beta-carboxylate
L0327

Research Excerpts

Overview

Loteprednol etabonate (LE) is a new generation corticosteroid that is used for the treatment of inflammatory and allergic conditions of the eye. It is rapidly deactivated after reaching the general circulation, displaying good local activity and a high therapeutic index without inducing systemic side effects.

ExcerptReferenceRelevance
"Loteprednol etabonate is a soft corticosteroid that is rapidly deactivated after reaching the general circulation, displaying good local activity and a high therapeutic index without inducing systemic side effects. "( Loteprednol etabonate: a formulation for short-term use in inflammatory flares in dry eye disease.
Paton, DM, 2022
)
3.61
"Loteprednol etabonate (LE) is a new generation corticosteroid that is used for the treatment of inflammatory and allergic conditions of the eye. "( Development of lipid nanoparticles for transdermal loteprednol etabonate delivery.
Özdemir, S; Özsoy, Y; Taş, Ç; Üner, B; Üner, M, 2022
)
2.42
"Loteprednol etabonate (LE) is a topical corticosteroid that uses inflammatory conditions of the eye. "( Loteprednol-Loaded Nanoformulations for Corneal Delivery by Quality-by-Design Concepts: Optimization, Characterization, and Anti-inflammatory Activity.
Ozdemir, S; Ozsoy, Y; Tas, C; Uner, B; Uner, M, 2023
)
2.35
"Loteprednol etabonate (LE) is a carbon-20 ester corticosteroid developed through retrometabolic drug design with potent anti-inflammatory effects and a reduced propensity for eliciting corticosteroid class AEs."( Innovations in topical ocular corticosteroid therapy for the management of postoperative ocular inflammation and pain.
Gaynes, BI; Rajpal, RK; Salinger, CL, 2019
)
1.24
"Loteprednol etabonate (LE) is a retrometabolically designed corticosteroid with a low propensity to cause corticosteroid-related adverse effects, such as elevated intraocular pressure (IOP)."( Loteprednol Etabonate for the Treatment of Dry Eye Disease.
Beckman, K; Katz, J; Majmudar, P; Rostov, A, 2020
)
2.72
"Loteprednol etabonate is a mainstay for topical therapy of a wide variety of commonplace and niche conditions of the ocular surface and the anterior segment, including in the healing post-operative patient. "( Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid.
Comstock, TL; Sheppard, JD, 2018
)
3.37
"Loteprednol etabonate (LE) is a soft corticosteroid with two labile ester bonds at 17α- and 17β-positions. "( Development of simultaneous quantification method of loteprednol etabonate (LE) and its acidic metabolites, and analysis of LE metabolism in rat.
Imai, T; Kage, A; Ohura, K; Samir, A, 2019
)
2.21
"Loteprednol etabonate (LE) is a soft corticosteroid that maintains therapeutic activity with much reduced adverse effects. "( Potential Use of Cyclodextrin Complexes for Enhanced Stability, Anti-inflammatory Efficacy, and Ocular Bioavailability of Loteprednol Etabonate.
El-Dahan, MS; Khatera, NAA; Mohamed, EAM; Soliman, OAE, 2017
)
2.11
"Loteprednol etabonate (LE) is a unique C-20 ester corticosteroid designed to produce a predictable therapeutic effect with a low incidence of side effects."( Loteprednol and tobramycin in combination: a review of their impact on current treatment regimens.
Comstock, TL; Holland, EJ, 2010
)
1.08
"Loteprednol etabonate 0.2% is a safe topical steroid when used on a long-term basis for the treatment of seasonal and perennial allergic conjunctivitis."( Long-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitis.
Braswell, GR; Favetta, JR; Ilyas, H; Schulman, M; Slonim, CB, 2004
)
2.09
"Loteprednol etabonate (LE) is a glucocorticoid soft drug that is currently in development for intranasal use. "( Intranasal loteprednol etabonate in healthy male subjects: pharmacokinetics and effects on endogenous cortisol.
Derendorf, H; Hermann, R; Hochhaus, G; LaVallee, N; Locher, M; Siebert-Weigel, M, 2004
)
2.16
"Loteprednol etabonate (LE) is a novel soft steroid that was designed to improve the benefit/risk ratio of topical corticosteroid therapy. "( Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit.
Geldmacher, H; Heermann, R; Hermann, R; Hohlfeld, JM; Krug, N; Larbig, M; Lavallee, N; Nguyen, DT; Petzold, U, 2005
)
2.17
"Loteprednol etabonate (LE) is an ester corticosteroid with a high therapeutic index that contains an ester, rather than a ketone, at carbon-20 of the prednisolone core structure."( Treatment of ocular inflammatory conditions with loteprednol etabonate.
Decory, HH; Pavesio, CE, 2008
)
1.32
"Loteprednol etabonate (LE) is a novel steroid with a low tendency to raise IOP. "( Loteprednol etabonate: comparison with other steroids in two models of intraocular inflammation.
Baru, H; Howes, JF; Neumann, R; Vered, M, 1994
)
3.17
"Loteprednol etabonate (LE) is a new corticosteroid based on the "soft drug" concept. "( Safety and efficacy of loteprednol etabonate for treatment of papillae in contact lens-associated giant papillary conjunctivitis.
Amos, JF; Bartlett, JD; Ghormley, NR; Horwitz, B; Howes, JF; Laibovitz, R, 1993
)
2.04
"Loteprednol etabonate is a novel site-active corticosteroid synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. "( Change in intraocular pressure during long-term use of loteprednol etabonate.
Crockett, RS; Howes, J; Novack, GD; Sherwood, MB, 1998
)
1.99
"Loteprednol etabonate is a site-active corticosteroid with efficacy and safety in treating ocular inflammation at the 0.5% concentration. "( A randomized, double-masked, placebo-controlled parallel study of 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitis.
Dell, SJ; Hart, K; Howes, J; Lowry, GM; Northcutt, JA; Novack, GD, 1998
)
1.98
"Loteprednol etabonate (LE) is a corticosteroid designed using the "soft drug" concept of Bodor. "( Loteprednol etabonate: a review of ophthalmic clinical studies.
Howes, JF, 2000
)
3.19
"Loteprednol etabonate (LE) is a "soft" steroid belonging to a unique class of glucocorticoids. "( Ocular absorption and distribution of loteprednol etabonate, a soft steroid, in rabbit eyes.
Bodor, N; Druzgala, P; Wu, WM, 1991
)
2

Effects

ExcerptReferenceRelevance
"Loteprednol etabonate has been developed on the basis of the retrometabolic drug design."( Possibilities in improvement of glucocorticoid treatments in asthma with special reference to loteprednol etabonate.
Hermann, R; Hochhaus, G; Pahl, A; Petzold, U; Szelenyi, I, 2004
)
1.26

Treatment

ExcerptReferenceRelevance
"Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P<0.05). "( Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%.
Donnenfeld, ED; Holland, EJ; Lane, SS; McDonald, MB; Perry, HD; Pflugfelder, SC; Samudre, SS; Sheppard, JD; Slonim, CB; Solomon, KD; Solomon, R, 2014
)
2.25

Toxicity

There were no reported adverse effects of long-term loteprednol etabonate 0.

ExcerptReferenceRelevance
"As a safe anti-inflammatory corticosteroid, the utility of loteprednol etabonate (LE) for the treatment of gastrointestinal inflammation, via oral and rectal administration, was investigated in rats."( Soft drugs. 18. Oral and rectal delivery of loteprednol etabonate, a novel soft corticosteroid, in rats--for safer treatment of gastrointestinal inflammation.
Bodor, N; Murakami, T; Wu, WM, 1995
)
0.8
" Chart review of slitlamp findings and intraocular pressure measurements during follow-up visits was performed to determine the incidence of adverse effects, such as steroid-induced intraocular pressure increase, cataract formation, and any other possible topical steroid-induced adverse event."( Long-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitis.
Braswell, GR; Favetta, JR; Ilyas, H; Schulman, M; Slonim, CB, 2004
)
0.65
"2% is a safe topical steroid when used on a long-term basis for the treatment of seasonal and perennial allergic conjunctivitis."( Long-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitis.
Braswell, GR; Favetta, JR; Ilyas, H; Schulman, M; Slonim, CB, 2004
)
0.65
" Safety endpoints included visual acuity (VA), biomicroscopy, intraocular pressure (IOP) assessments, and adverse events."( Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis.
Bateman, KM; Comstock, TL; Macy, JI; White, EM, 2008
)
0.35
" Safety evaluation included adverse events, biomicroscopy findings, and changes in VA and IOP."( A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis.
Chen, M; Gong, L; Gu, Y; He, X; Qu, J; Sun, X; Wang, L; Zhang, M; Zhong, X, 2012
)
0.6
" LE/T was shown to be safe in healthy volunteers and patients aged 18 years and older with minimal effect on intraocular pressure (IOP)."( Safety and tolerability of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension in pediatric subjects.
Bateman, KM; Comstock, TL; Decory, HH; Gearinger, M; Paterno, MR, 2012
)
0.68
" Treatment-emergent ocular and non-ocular adverse events (AEs) and bilateral vision were assessed at all study visits in both studies."( Safety and tolerability of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension in pediatric subjects.
Bateman, KM; Comstock, TL; Decory, HH; Gearinger, M; Paterno, MR, 2012
)
0.68
" Adverse event reports including elevation of intraocular pressure (IOP) were recorded."( Topical loteprednol etabonate 0.5 % for treatment of vernal keratoconjunctivitis: efficacy and safety.
Alakuş, MF; Işcan, Y; Oner, V; Taş, M; Türkcü, FM, 2012
)
0.81
"Topical corticosteroids are routinely used as postoperative ocular anti-inflammatory drugs; however, adverse effects such as increased intraocular pressure (IOP) are observed with their use."( Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use.
Amon, M; Busin, M, 2012
)
1.82
" Safety measures included adverse events, intraocular pressure (IOP), visual acuity, biomicroscopy and funduscopy findings, and tolerability (ocular symptoms and drop comfort)."( Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery.
Erb, T; Rajpal, RK; Roel, L; Siou-Mermet, R, 2013
)
0.7
"5% was efficacious and safe in treating postoperative inflammation and pain."( Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery.
Erb, T; Rajpal, RK; Roel, L; Siou-Mermet, R, 2013
)
0.7
" Main safety assessments were adverse events (AEs) and intraocular pressure (IOP)."( Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies.
Brazzell, K; Coultas, S; Evans, D; Foulks, G; Goldberg, D; Korenfeld, M; Nichols, KK; Sall, K, 2021
)
0.62
"25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials."( Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies.
Brazzell, K; Coultas, S; Evans, D; Foulks, G; Goldberg, D; Korenfeld, M; Nichols, KK; Sall, K, 2021
)
0.62

Pharmacokinetics

The study describes a new reversed-phase high-performance liquid chromatographic method for the determination of levels of drug in plasma and urine samples. It assesses the pharmacokinetic properties of loteprednol etabonate in dogs and rats.

ExcerptReferenceRelevance
" As the basis for human trials, this study describes a new reversed-phase high-performance liquid chromatographic method for the determination of levels of drug in plasma and urine samples and assesses the pharmacokinetic properties of loteprednol etabonate in dogs and rats."( Pharmacokinetic characterization and tissue distribution of the new glucocorticoid soft drug loteprednol etabonate in rats and dogs.
Bodor, N; Chen, LS; Derendorf, H; Druzgala, P; Hochhaus, G; Howes, J; Ratka, A, 1992
)
0.69
"The pharmacokinetic studies were performed by iv injections of LE (1-20 mg/kg)."( Soft drugs. 19. Pharmacokinetics, metabolism and excretion of a novel soft corticosteroid, loteprednol etabonate, in rats.
Bodor, N; Engel, S; Murakami, T; Wu, WM, 1995
)
0.51
"The pharmacokinetic of LE showed a rapid, dose-dependent elimination with a total blood clearance (CLtotal) of higher than 60 ml/min/kg."( Soft drugs. 19. Pharmacokinetics, metabolism and excretion of a novel soft corticosteroid, loteprednol etabonate, in rats.
Bodor, N; Engel, S; Murakami, T; Wu, WM, 1995
)
0.51
" Drug trough levels were determined on days 1, 5, 12, 13, and 14, and a full pharmacokinetic profile was established on day 14, and 24-hour serum cortisol profiles were assessed prior to treatment (i."( Intranasal loteprednol etabonate in healthy male subjects: pharmacokinetics and effects on endogenous cortisol.
Derendorf, H; Hermann, R; Hochhaus, G; LaVallee, N; Locher, M; Siebert-Weigel, M, 2004
)
0.71
" Pharmacokinetic studies (two-compartment model, 10 mg kg(-1) intra-venous bolus of AE or A) found the elimination of both AE (t(1/2)(beta), 12."( Pharmacokinetics of the sequential metabolites of loteprednol etabonate in rats.
Bodor, N; Buchwald, P; Huang, F; Lee, Y; Wu, WM, 2008
)
0.6
"Detailed pharmacokinetic (PK) studies in rats were performed (i)to compare the PK of prednisolone (PRN) and loteprednol etabonate (LE, a soft corticosteroid) as well as their common inactive metabolite delta1-cortienic acid (delta1-CA), (ii) to investigate the excretion of delta1-CA after PRN and LE administration, and (iii) to investigate the effect of delta1-unsaturation on the excretion of delta1-CA versus CA."( Pharmacokinetics and delta1-cortienic acid excretion after intravenous administration of prednisolone and loteprednol etabonate in rats.
Bodor, N; Buchwald, P; Tang, Y; Wu, WM, 2010
)
0.79
" Thus, the combination of delta1-CA with LE serves an enhancing and stabilizing role while not impacting the pharmacokinetic properties of LE."( The effects of delta1-cortienic acid on skin blanching, pharmacokinetics and stability of loteprednol etabonate.
Bodor, ET; Bodor, N; Howes, J; Wu, WM, 2012
)
0.6

Bioavailability

ExcerptReferenceRelevance
" Yet, its ocular bioavailability is hindered by its poor aqueous solubility."( Potential Use of Cyclodextrin Complexes for Enhanced Stability, Anti-inflammatory Efficacy, and Ocular Bioavailability of Loteprednol Etabonate.
El-Dahan, MS; Khatera, NAA; Mohamed, EAM; Soliman, OAE, 2017
)
0.66
" Recently, strategies for improving ocular penetration of ophthalmic formulations have included use of mucoadhesive formulations (ie, polycarbophil-containing gels) and drug particle size reduction, enabling faster drug dissolution and therefore increased bioavailability and penetration."( Innovations in topical ocular corticosteroid therapy for the management of postoperative ocular inflammation and pain.
Gaynes, BI; Rajpal, RK; Salinger, CL, 2019
)
0.51
" It has a low ocular bioavailability and side effects such as corneal disorder, eye discharge, and ocular discomfort."( Loteprednol-Loaded Nanoformulations for Corneal Delivery by Quality-by-Design Concepts: Optimization, Characterization, and Anti-inflammatory Activity.
Ozdemir, S; Ozsoy, Y; Tas, C; Uner, B; Uner, M, 2023
)
0.91

Dosage Studied

ExcerptRelevanceReference
" The dosing and testing regimen was similar to the first portion of the study."( The conjunctival provocation test model of ocular allergy: utility for assessment of an ocular corticosteroid, loteprednol etabonate.
Abelson, M; George, M; Howes, J, 1998
)
0.51
" These values were sustained throughout dosing but declined rapidly to baseline upon cessation of treatment."( Pharmacological validation of a feline model of steroid-induced ocular hypertension.
Bhattacherjee, P; Graff, G; Paterson, CA; Spellman, JM; Yanni, JM, 1999
)
0.3
" However, a range of unwanted side effects and the often complex dosing schedules associated with these drugs frequently result in poor patient compliance."( Soft steroids: a new approach to the treatment of inflammatory airways diseases.
Belvisi, MG; Hele, DJ, 2003
)
0.32
" It provides uniform dosing of a topical ophthalmic corticosteroid that has been demonstrated to be effective and well-tolerated in the treatment of ocular inflammation."( Loteprednol etabonate ophthalmic gel 0.5%: a review of its use in post-operative inflammation and pain following ocular surgery.
Lyseng-Williamson, KA, 2013
)
1.83
" Dosing was 4 times daily for 2 months, thrice daily for 1 month, twice daily for 1 month, and once daily for 7 months."( Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial.
Feng, MT; Price, FW; Price, MO; Scanameo, A, 2015
)
1.86
" In all studies, LE consistently demonstrated a low propensity to elevate IOP, regardless of formulation, dosage regimen, or treatment duration, including in known steroid responders."( Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure.
Cavet, ME; Comstock, TL; Sheppard, JD, 2016
)
0.69
"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
)
0.81
" 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
)
0.81
"38%) and dosing frequency."( Innovations in topical ocular corticosteroid therapy for the management of postoperative ocular inflammation and pain.
Gaynes, BI; Rajpal, RK; Salinger, CL, 2019
)
0.51
"25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials."( Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies.
Brazzell, K; Coultas, S; Evans, D; Foulks, G; Goldberg, D; Korenfeld, M; Nichols, KK; Sall, K, 2021
)
0.62
"All formulations were able to cover postoperative periods commensurate with commonly used dosing regimens for cataract surgery."( Fill levels, cost comparisons, and expulsion force requirements of commonly used topical ophthalmic steroids.
Dvorak, JD; Gill, MS; Murphy, DA; Riaz, KM; Shah, SV, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
anti-inflammatory drugA substance that reduces or suppresses inflammation.
[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 (6)

ClassDescription
etabonate ester
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
steroid ester
organochlorine compoundAn organochlorine compound is a compound containing at least one carbon-chlorine bond.
steroid acid ester
3-oxo-Delta(1),Delta(4)-steroidA 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
[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]

Protein Targets (26)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
hypoxia-inducible factor 1 alpha subunitHomo sapiens (human)Potency3.37803.189029.884159.4836AID1224846
RAR-related orphan receptor gammaMus musculus (house mouse)Potency31.61800.006038.004119,952.5996AID1159523
SMAD family member 2Homo sapiens (human)Potency11.98560.173734.304761.8120AID1346859
PPM1D proteinHomo sapiens (human)Potency0.04660.00529.466132.9993AID1347411
SMAD family member 3Homo sapiens (human)Potency11.98560.173734.304761.8120AID1346859
GLI family zinc finger 3Homo sapiens (human)Potency0.01680.000714.592883.7951AID1259369
AR proteinHomo sapiens (human)Potency0.24880.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID743036; AID743040; AID743042; AID743053; AID743054
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency22.42090.001022.650876.6163AID1224838; AID1224893
progesterone receptorHomo sapiens (human)Potency0.19980.000417.946075.1148AID1346784; AID1347036
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.08420.000214.376460.0339AID720691; AID720692; AID720719
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency0.33490.003041.611522,387.1992AID1159553
pregnane X nuclear receptorHomo sapiens (human)Potency10.04050.005428.02631,258.9301AID1346982; AID1346985
estrogen nuclear receptor alphaHomo sapiens (human)Potency9.17760.000229.305416,493.5996AID743075; AID743077; AID743079; AID743091
peroxisome proliferator-activated receptor deltaHomo sapiens (human)Potency23.70830.001024.504861.6448AID743212
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency11.88230.001019.414170.9645AID743191
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency23.81280.023723.228263.5986AID743222; AID743241
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.29850.001723.839378.1014AID743083
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_aHomo sapiens (human)Potency6.740019.739145.978464.9432AID1159509
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency19.96820.000323.4451159.6830AID743065; AID743067
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency10.59010.000627.21521,122.0200AID743202; AID743219
Interferon betaHomo sapiens (human)Potency0.04660.00339.158239.8107AID1347411
Cellular tumor antigen p53Homo sapiens (human)Potency23.71010.002319.595674.0614AID651631
[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)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)15.52000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)40.40000.11007.190310.0000AID1473738
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (194)

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)
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)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (61)

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)
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)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (37)

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)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (58)

Assay IDTitleYearJournalArticle
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.
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.
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.
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.
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.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
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.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
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.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
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.
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.
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.
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.
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
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.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
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.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
AID1347412qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation2020ACS 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.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS 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.
AID1473739Inhibition 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.
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.
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.
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.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (161)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's33 (20.50)18.2507
2000's31 (19.25)29.6817
2010's71 (44.10)24.3611
2020's26 (16.15)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 70.25

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 Index70.25 (24.57)
Research Supply Index5.38 (2.92)
Research Growth Index4.80 (4.65)
Search Engine Demand Index122.50 (26.88)
Search Engine Supply Index2.04 (0.95)

This Compound (70.25)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials49 (29.17%)5.53%
Reviews20 (11.90%)6.00%
Case Studies16 (9.52%)4.05%
Observational1 (0.60%)0.25%
Other82 (48.81%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (60)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification [NCT01193504]Phase 4100 participants (Anticipated)Interventional2010-09-30Recruiting
A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery [NCT01060072]Phase 3407 participants (Actual)Interventional2010-02-28Completed
Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery [NCT01344226]49 participants (Actual)Observational2011-04-30Completed
The CLEAN Study: Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization-A Prospective Cohort Study of Combination Therapy in the Treatment of Dry Eye [NCT05322148]Phase 359 participants (Actual)Interventional2022-06-03Completed
Efficiency and Safety of Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis: a Non-randomized Controlled Study [NCT05353101]Phase 148 participants (Actual)Interventional2020-07-01Completed
A Phase 3, Multi-Center, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) Versus Vehicle Gel [NCT02786901]Phase 3600 participants (Actual)Interventional2016-06-30Completed
A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis [NCT01028027]Phase 3357 participants (Actual)Interventional2009-10-31Completed
[NCT01010633]Phase 3406 participants (Actual)Interventional2009-11-30Completed
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis [NCT00705159]Phase 4137 participants (Actual)Interventional2008-06-30Completed
A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects [NCT00420628]Phase 4108 participants (Actual)Interventional2006-11-30Completed
A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery [NCT00645671]Phase 3400 participants (Actual)Interventional2008-03-31Completed
Evaluation of Steroidal Treatment For Dry Eye Disease [NCT02218827]30 participants (Anticipated)Interventional2014-09-30Not yet recruiting
A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery [NCT00781300]Phase 435 participants (Actual)Interventional2006-03-31Completed
A Randomized Clinical Trial: Comparison of the Efficacy of Topical 0.2% Loteprednol Etabonate and Topical 0.1% Dexamethasone in Impending Recurrent Pterygium [NCT04075227]Phase 4108 participants (Actual)Interventional2015-10-16Completed
Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery [NCT00699153]Phase 3400 participants (Actual)Interventional2008-06-30Completed
Use of Loteprednol for Contact Lens Intolerance and Dryness [NCT00817557]Phase 425 participants (Anticipated)Interventional2009-01-31Enrolling by invitation
A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery [NCT03531697]Phase 1381 participants (Actual)Interventional2018-04-26Completed
[NCT02028312]Phase 40 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to Per Sponsor)
Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model [NCT01107405]Phase 2101 participants (Actual)Interventional2010-04-30Completed
A Double-Masked, Randomized, Placebo-Controlled Study of Loteprednol Etabonate Ophthalmic Suspension, 0.5% for the Treatment of Dry Eye Used Either TID or QID for a 2 Week Period [NCT00560638]Phase 2119 participants (Actual)Interventional2005-11-30Completed
Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Rest [NCT04555694]Phase 430 participants (Actual)Interventional2020-10-01Completed
Association of Azithromycin 1,5%/Loteprednol 0,5% Eye Drops Versus Individual Administration of Azithromycin 1,5% and Loteprednol 0,5% in the Treatment of Ocular Inflammation and Infection [NCT01721694]Phase 30 participants (Actual)Interventional2012-12-31Withdrawn(stopped due to withdrawn by industry)
Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty [NCT05136443]Phase 471 participants (Actual)Interventional2021-11-23Completed
A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers [NCT00532961]Phase 4310 participants (Actual)Interventional2005-02-28Completed
[NCT00834171]50 participants (Actual)Observational2009-01-31Completed
A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis [NCT00447577]Phase 4276 participants (Actual)Interventional2007-01-31Completed
A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine [NCT00407043]Phase 45 participants (Actual)Interventional2006-11-30Completed
A Single-Center, Masked, Randomized Study Comparing Bepreve (Bepotastine Besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (Loteprednol Etabonate) 0.2% - Corticosteroid in Subjects With Moderate to Severe Allergic Conjunctivitis [NCT01443442]Phase 423 participants (Actual)Interventional2011-10-31Completed
Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery [NCT01996839]Phase 3514 participants (Actual)Interventional2013-12-31Completed
Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology Effected by Lotemax [NCT02322528]10 participants (Actual)Interventional2014-04-30Completed
DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis [NCT04708821]Phase 431 participants (Actual)Interventional2021-04-30Completed
A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation [NCT02163824]Phase 3380 participants (Actual)Interventional2014-05-31Completed
[NCT01692652]98 participants (Actual)Interventional2012-08-31Completed
The Utility of in Vivo Confocal Microscopy (IVCM) to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With Dry Eye Disease (DED) [NCT02120079]Phase 438 participants (Actual)Interventional2014-02-28Completed
[NCT01724892]Phase 432 participants (Actual)Interventional2012-11-30Completed
Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery [NCT01749241]0 participants (Actual)Interventional2012-09-30Withdrawn(stopped due to no participant enrolled)
A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease [NCT02813265]Phase 3918 participants (Actual)Interventional2016-06-30Completed
Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol [NCT01695668]75 participants (Actual)Interventional2011-08-31Completed
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% [NCT01437982]Phase 4140 participants (Anticipated)Interventional2010-08-05Completed
Comparison of Acular LS With Lotemax to Prevent Anterior Segment Inflammation After Phacoemulsification and Intraocular Lens Implantation [NCT00366691]Phase 440 participants Interventional2006-02-28Completed
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain [NCT05542381]72 participants (Anticipated)Interventional2022-12-22Recruiting
Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract [NCT01475643]Phase 3107 participants (Actual)Interventional2013-06-30Completed
Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery [NCT02208297]Phase 3326 participants (Actual)Interventional2014-09-30Completed
A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC) [NCT01435460]Phase 3300 participants (Actual)Interventional2010-08-31Completed
A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease [NCT02819284]Phase 3909 participants (Actual)Interventional2016-06-30Completed
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% at 6, 9, 12, and 24 Hours Following a Single Instillation in Healthy Volunteers [NCT01736527]Phase 112 participants (Actual)Interventional2013-01-31Completed
Randomized, Single Blinded Controlled Trial for Evaluation of the Safety and Efficacy of Loteprednol Versus Fluorometholone After Photorefractive Keratectomy for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study [NCT02974387]Phase 4200 participants (Anticipated)Interventional2017-04-30Not yet recruiting
A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain [NCT02793817]Phase 3520 participants (Actual)Interventional2016-06-30Completed
Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension [NCT03123614]Phase 4131 participants (Actual)Interventional2014-09-19Completed
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers [NCT03063489]Phase 115 participants (Actual)Interventional2015-02-28Completed
Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty [NCT01853696]Phase 4167 participants (Actual)Interventional2013-03-31Completed
A Randomized, Multi-Center, Parallel-Group, Safety and Efficacy Study of Lotemax® Gel 0.5% and Restasis 0.05% for 12 Weeks in Subjects With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease; DED) [NCT01817582]Phase 2102 participants (Actual)Interventional2013-05-17Completed
Safety and Efficacy of Intracanalicular Dexamethasone Insert Compared to Loteprednol Etabonate Ophthalmic Gel 0.38% in Patients With Keratoconus Wearing Gas Permeable Contact Lenses Who Have Been Diagnosed With Allergic Conjunctivitis [NCT04418999]Early Phase 118 participants (Actual)Interventional2020-09-01Completed
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel [NCT03098953]Phase 115 participants (Actual)Interventional2017-04-10Completed
Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model [NCT00689078]Phase 436 participants (Actual)Interventional2008-05-31Completed
An Exploratory, Multi-Center, Randomized, Single-Masked Study Evaluating the Effect of KPI-121 on Intraretinal or Subretinal Fluid Secondary to Retinal Vein Occlusion or Diabetic Macular Edema [NCT02245516]16 participants (Actual)Interventional2014-07-31Completed
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis [NCT03464435]Phase 420 participants (Actual)Interventional2016-11-01Completed
Relative Efficacy of Loteprednol (Lotemax®) vs. Loteprednol/Tobramycin (Zylet®) in Treatment of Chronic Ocular Surface Inflammation Associated With Meibomian Gland Dysfunction (MGD)/Posterior Blepharitis [NCT01456780]Phase 460 participants (Actual)Interventional2011-08-31Completed
A Phase II, Double-Masked, Randomized, Vehicle-Controlled Study to Evaluate the Effect of KPI-121 0.25% Ophthalmic Suspension on Signs and Symptoms of Inflammatory Meibomian Gland Disease [NCT02218489]Phase 2206 participants (Actual)Interventional2014-07-31Completed
A Phase II, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease [NCT02188160]Phase 2150 participants (Actual)Interventional2014-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00420628 (5) [back to overview]Treatment Emergent Adverse Events
NCT00420628 (5) [back to overview]Assessment of Ocular Signs in the Study Eye - Visit 1
NCT00420628 (5) [back to overview]Assessment of Ocular Signs in the Study Eye - Visit 2
NCT00420628 (5) [back to overview]Assessment of Ocular Signs in the Study Eye - Visit 3
NCT00420628 (5) [back to overview]Investigators Global Assessment of the Clinical Condition
NCT00645671 (4) [back to overview]Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.
NCT00645671 (4) [back to overview]Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.
NCT00645671 (4) [back to overview]Grade 0 for Pain
NCT00645671 (4) [back to overview]Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
NCT00689078 (10) [back to overview]Ocular Redness at Day 7
NCT00689078 (10) [back to overview]Ocular Itching at Day 6
NCT00689078 (10) [back to overview]Ocular Redness at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Redness at Day 27
NCT00689078 (10) [back to overview]Ocular Redness at Day 28
NCT00689078 (10) [back to overview]Ocular Redness at Day 6
NCT00689078 (10) [back to overview]Ocular Itching at Day 7
NCT00689078 (10) [back to overview]Ocular Itching at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Itching at Day 27
NCT00689078 (10) [back to overview]Ocular Itching at Day 28
NCT00699153 (4) [back to overview]Participants With Grade 0 (no) Pain
NCT00699153 (4) [back to overview]Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
NCT00699153 (4) [back to overview]Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
NCT00699153 (4) [back to overview]Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
NCT00705159 (3) [back to overview]Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
NCT00705159 (3) [back to overview]Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
NCT00705159 (3) [back to overview]Change From Baseline in the Total Blepharoconjunctivitis Grade.
NCT00834171 (1) [back to overview]Mean Elevated Intraocular Pressure (IOP) During Treatment
NCT01010633 (3) [back to overview]Resolution of Anterior Chamber Cells (ACC).
NCT01010633 (3) [back to overview]Resolution of Anterior Chamber Cells.
NCT01010633 (3) [back to overview]Grade 0 Pain
NCT01028027 (6) [back to overview]Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
NCT01028027 (6) [back to overview]Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
NCT01028027 (6) [back to overview]Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
NCT01028027 (6) [back to overview]Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
NCT01028027 (6) [back to overview]Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
NCT01028027 (6) [back to overview]Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
NCT01060072 (5) [back to overview]Resolution of Anterior Chamber Cells.
NCT01060072 (5) [back to overview]Grade 0 Pain
NCT01060072 (5) [back to overview]Resolution of Anterior Chamber Cells
NCT01060072 (5) [back to overview]Resolution of Anterior Chamber Flare
NCT01060072 (5) [back to overview]Grade 0 Pain
NCT01107405 (6) [back to overview]Conjunctival Redness
NCT01107405 (6) [back to overview]Conjunctival Redness
NCT01107405 (6) [back to overview]Ocular Itching
NCT01107405 (6) [back to overview]Ocular Itching
NCT01107405 (6) [back to overview]Ocular Itching
NCT01107405 (6) [back to overview]Conjunctival Redness
NCT01344226 (4) [back to overview]Flare Scores in Early Postoperative Period
NCT01344226 (4) [back to overview]ETDRS Letters Read Over Early Postoperative Period
NCT01344226 (4) [back to overview]Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.
NCT01344226 (4) [back to overview]Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification
NCT01435460 (4) [back to overview]Bulbar Conjunctival Injection
NCT01435460 (4) [back to overview]Ocular Itching
NCT01435460 (4) [back to overview]Ocular Itching
NCT01435460 (4) [back to overview]Bulbar Conjunctival Injection
NCT01443442 (1) [back to overview]Change From Baseline in Ocular Itching at 14 Days
NCT01456780 (4) [back to overview]Corneal Fluorescein Staining Score
NCT01456780 (4) [back to overview]Ocular Surface Disease Index
NCT01456780 (4) [back to overview]Symptom Assessment iN Dry Eye (SANDE) Frequency Score
NCT01456780 (4) [back to overview]Symptom Assessment iN Dry Eye (SANDE) Severity Score
NCT01475643 (2) [back to overview]Anterior Chamber Cells & Flare
NCT01475643 (2) [back to overview]Anterior Chamber Inflammation
NCT01695668 (1) [back to overview]Progression of Dry Eye Severity
NCT01736527 (4) [back to overview]Tear Fluid Levels
NCT01736527 (4) [back to overview]Tear Fluid Levels
NCT01736527 (4) [back to overview]Tear Fluid Levels
NCT01736527 (4) [back to overview]Tear Fluid Levels
NCT01817582 (19) [back to overview]Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Tear Osmolarity Between Two Eyes of Participant at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator
NCT01817582 (19) [back to overview]Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator
NCT01817582 (19) [back to overview]Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants
NCT01817582 (19) [back to overview]Averaged Daily Soothe Lubricant Eye Drops Usage
NCT01817582 (19) [back to overview]Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4
NCT01817582 (19) [back to overview]Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4
NCT01817582 (19) [back to overview]Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values
NCT01817582 (19) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT01817582 (19) [back to overview]Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13
NCT01817582 (19) [back to overview]Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12
NCT01817582 (19) [back to overview]Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12
NCT01853696 (2) [back to overview]Intraocular Pressure
NCT01853696 (2) [back to overview]Immunologic Graft Rejection Episode
NCT01996839 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
NCT01996839 (6) [back to overview]Percentage of Participants With Grade 0 Pain in the Study Eye.
NCT01996839 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
NCT01996839 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
NCT01996839 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
NCT01996839 (6) [back to overview]Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
NCT02120079 (16) [back to overview]Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
NCT02120079 (16) [back to overview]Ocular Signs: Schirmer's Test With Anesthesia
NCT02120079 (16) [back to overview]Ocular Signs: Schirmer's Test With Anesthesia
NCT02120079 (16) [back to overview]Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
NCT02120079 (16) [back to overview]Ocular Signs: Tear Break Up Time (TBUT)
NCT02120079 (16) [back to overview]IVCM for Density of Corneal Immune Dendritiform Cells
NCT02120079 (16) [back to overview]Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
NCT02120079 (16) [back to overview]Ocular Signs: Corneal Epitheliopathy
NCT02120079 (16) [back to overview]Ocular Signs: Corneal Epitheliopathy
NCT02120079 (16) [back to overview]Ocular Signs: Conjunctival Epitheliopathy
NCT02120079 (16) [back to overview]IVCM for Density of Corneal Immune Dendritiform Cells
NCT02120079 (16) [back to overview]IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
NCT02120079 (16) [back to overview]IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
NCT02120079 (16) [back to overview]Ocular Signs: Conjunctival Epitheliopathy
NCT02120079 (16) [back to overview]Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
NCT02120079 (16) [back to overview]Ocular Signs: Tear Break Up Time (TBUT)
NCT02163824 (6) [back to overview]Anterior Chamber Cell Grade at Visit 6.
NCT02163824 (6) [back to overview]Ocular Pain Grades at Day 15.
NCT02163824 (6) [back to overview]Ocular Pain Grades at Day 8.
NCT02163824 (6) [back to overview]Resolution of Anterior Chamber Cells
NCT02163824 (6) [back to overview]Resolution of Ocular Pain
NCT02163824 (6) [back to overview]Anterior Chamber Cell Grade at Visit 5.
NCT02188160 (5) [back to overview]Corneal Fluorescein Staining Scores
NCT02188160 (5) [back to overview]Bulbar Conjunctival Hyperemia
NCT02188160 (5) [back to overview]Bulbar Conjunctival Hyperemia Scores
NCT02188160 (5) [back to overview]Ocular Discomfort
NCT02188160 (5) [back to overview]Ocular Discomfort
NCT02208297 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
NCT02208297 (6) [back to overview]Percentage of Participants With Grade 0 Pain in the Study Eye.
NCT02208297 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
NCT02208297 (6) [back to overview]Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
NCT02208297 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
NCT02208297 (6) [back to overview]Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
NCT02218489 (6) [back to overview]Change From Baseline in Ocular Discomfort
NCT02218489 (6) [back to overview]Change From Baseline in Ocular Discomfort
NCT02218489 (6) [back to overview]Change From Baseline in Posterior Lid Margin Hyperemia
NCT02218489 (6) [back to overview]Change From Baseline in Posterior Lid Margin Hyperemia
NCT02218489 (6) [back to overview]Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
NCT02218489 (6) [back to overview]Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline
NCT02245516 (3) [back to overview]Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)
NCT02245516 (3) [back to overview]Macular Volume by SD-OCT
NCT02245516 (3) [back to overview]Center Subfield Retinal Thickness by SD-OCT
NCT02322528 (2) [back to overview]Visual Quality
NCT02322528 (2) [back to overview]Ocular Surface Temperature of Both Eyes
NCT02786901 (8) [back to overview]Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit
NCT02786901 (8) [back to overview]Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)
NCT02786901 (8) [back to overview]Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit.
NCT02786901 (8) [back to overview]Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit
NCT02786901 (8) [back to overview]Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit
NCT02786901 (8) [back to overview]Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit
NCT02786901 (8) [back to overview]Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)
NCT02786901 (8) [back to overview]Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8)
NCT02793817 (7) [back to overview]Complete Resolution of Anterior Chamber (AC) Cells at Day 8
NCT02793817 (7) [back to overview]Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 8
NCT02793817 (7) [back to overview]Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4
NCT02793817 (7) [back to overview]Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 15
NCT02793817 (7) [back to overview]Complete Resolution of Ocular Pain at Day 8
NCT02793817 (7) [back to overview]Complete Resolution of Ocular Pain at Day 4
NCT02793817 (7) [back to overview]Complete Resolution of Anterior Chamber (AC) Flare at Day 4
NCT02813265 (13) [back to overview]Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)
NCT02813265 (13) [back to overview]Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)
NCT02813265 (13) [back to overview]Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)
NCT02813265 (13) [back to overview]Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)
NCT02813265 (13) [back to overview]Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)
NCT02813265 (13) [back to overview]Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)
NCT02813265 (13) [back to overview]Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.
NCT02813265 (13) [back to overview]Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort
NCT02813265 (13) [back to overview]Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
NCT02813265 (13) [back to overview]Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
NCT02813265 (13) [back to overview]Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort
NCT02813265 (13) [back to overview]Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
NCT02813265 (13) [back to overview]Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort
NCT02819284 (14) [back to overview]Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)
NCT02819284 (14) [back to overview]Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
NCT02819284 (14) [back to overview]Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)
NCT02819284 (14) [back to overview]Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)
NCT02819284 (14) [back to overview]Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)
NCT02819284 (14) [back to overview]Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup
NCT03123614 (4) [back to overview]Best Corrected Visual Acuity at 3 Months
NCT03123614 (4) [back to overview]Number of Eyes With Corneal Haze
NCT03123614 (4) [back to overview]Uncorrected Visual Acuity
NCT03123614 (4) [back to overview]Change in Intraocular Pressure (IOP) From Baseline Through Month 3
NCT04555694 (7) [back to overview]Mean Ocular Surface Staining From Baseline
NCT04555694 (7) [back to overview]Mean Conjunctival Staining
NCT04555694 (7) [back to overview]DEQ-5 Score
NCT04555694 (7) [back to overview]Tear Breakup Time (Seconds)
NCT04555694 (7) [back to overview]Tear Osmolarity
NCT04555694 (7) [back to overview]Meibomian Gland Scores
NCT04555694 (7) [back to overview]Mean Schirmer Tear Test 1 Score

Treatment Emergent Adverse Events

Study eye - Safety Population, At all visits 1,2,3 (NCT00420628)
Timeframe: day 1, day 8, day 15

,
Interventionparticipants (Number)
ConjunctivitisMeibomianitisEyelid edema
Loteprednol/Tobramycin210
Vehicle011

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Assessment of Ocular Signs in the Study Eye - Visit 1

Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. (NCT00420628)
Timeframe: Visit 1 (day 1)

,
InterventionUnits on a scale 0-4 (Mean)
Lid EdemaLid ErythemaPalpebral Conjunctival InjectionMeibomian Plugging
Loteprednol/Tobramycin1.971.981.851.44
Vehicle2.061.821.791.59

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Assessment of Ocular Signs in the Study Eye - Visit 2

Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. (NCT00420628)
Timeframe: Visit 2 (day 8)

,
InterventionUnits on a scale 0-4 (Mean)
Lid EdemaLid ErythemaPalpebral Conjunctival InjectionMeibomian Plugging
Loteprednol/Tobramycin1.471.411.411.06
Vehicle1.381.471.161.00

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Assessment of Ocular Signs in the Study Eye - Visit 3

Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. (NCT00420628)
Timeframe: Visit 3 (day 15)

,
InterventionUnits on a scale 0-4 (Mean)
Lid EdemaLid ErythemaPalpebral Conjunctival InjectionMeibomian Plugging
Loteprednol/Tobramycin1.031.001.110.86
Vehicle1.411.501.091.16

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Investigators Global Assessment of the Clinical Condition

The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened. (NCT00420628)
Timeframe: Visit 3, day 8

,
InterventionParticipants (Number)
ImprovedUnchangedWorse
Loteprednol/Tobramycin36252
Vehicle17132

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Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. (NCT00645671)
Timeframe: Postoperative Day 8 (Visit 5)

,
Interventionparticipants (Number)
YesNo
Loteprednol Etabonate48153
Vehicle27172

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Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. (NCT00645671)
Timeframe: At each follow-up visit through day18 (Visit 7)

,
Interventionparticipants (Number)
Visit 4 (postoperative day 3)Visit 5 (postoperative day 8)Visit 6 (postoperative day 15)Visit 7 (postoperative day 18)
Loteprednol Etabonate10488486
Vehicle9273039

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Grade 0 for Pain

Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe (NCT00645671)
Timeframe: Postoperative Day 8 (Visit 5)

,
Interventionparticipants (Number)
YesNo
Loteprednol Etabonate15645
Vehicle90109

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Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. (NCT00645671)
Timeframe: Baseline and each follow-up visit through day18 (Visit 7)

,
InterventionComposit scores (Mean)
Visit 4 (postoperative day 3)Visit 5 (postoperative day 8)Visit 6 (postoperative day 15)Visit 7 (postoperative day 18)
Loteprednol Etabonate-1.0-2.1-2.6-2.5
Vehicle-0.4-0.7-0.9-1.1

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Ocular Redness at Day 7

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.591.591.47
Pred Forte2.081.831.72
Pred Mild1.531.691.78
Tears Naturale1.591.661.5

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Ocular Itching at Day 6

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.062.412.31
Pred Forte2.172.442.17
Pred Mild2.192.592.72
Tears Naturale2.332.532.14

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Ocular Redness at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.862.112
Pred Forte2.112.332.22
Pred Mild2.112.312.28
Tears Naturale2.082.252.06

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Ocular Redness at Day 27

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.441.631.53
Pred Forte1.721.721.53
Pred Mild2.142.111.89
Tears Naturale1.561.721.72

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Ocular Redness at Day 28

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.691.691.69
Pred Forte1.581.811.5
Pred Mild1.962.111.86
Tears Naturale1.811.941.72

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Ocular Redness at Day 6

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.842.132.03
Pred Forte21.972
Pred Mild2.222.412.31
Tears Naturale2.112.282.17

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Ocular Itching at Day 7

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.092.031.88
Pred Forte2.112.111.97
Pred Mild2.282.692.75
Tears Naturale2.031.941.72

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Ocular Itching at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.613.063.08
Pred Forte2.532.923.03
Pred Mild3.083.473.44
Tears Naturale2.52.752.83

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Ocular Itching at Day 27

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex1.752.092
Pred Forte2.142.172.03
Pred Mild2.432.642.64
Tears Naturale2.031.841.72

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Ocular Itching at Day 28

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.0321.78
Pred Forte1.831.971.89
Pred Mild2.252.642.71
Tears Naturale1.751.781.56

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Participants With Grade 0 (no) Pain

Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe (NCT00699153)
Timeframe: Postoperative day 8 (Visit 5)

Interventionparticipants (Number)
Loteprednol Etabonate149
Vehicle83

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Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. (NCT00699153)
Timeframe: Postoperative Day 3-18 (Each follow-up Visit 4-7)

,
InterventionComposite scores (Mean)
Visit 4, postoperative day 3Visit 5, postoperative day 8Visit 6, postoperative day 15Visit 7, postoperative day 18
Loteprednol Etabonate-1.2-2.2-2.7-2.6
Vehicle-0.6-0.8-1.1-1.1

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Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. (NCT00699153)
Timeframe: At each visit: Visit 4-7, postoperative days 3-18

,
Interventionparticipants (Number)
Visit 4, postoperative day 3Visit 5, postoperative day 8Visit 6, posoperative day 15Visit 7, postoperative day 18
Loteprednol Etabonate1064107100
Vehicle9234246

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Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe. (NCT00699153)
Timeframe: Postoperative day 8 (Visit 5)

Interventionparticipants (Number)
Loteprednol Etabonate64
Vehicle23

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Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3

Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. (NCT00705159)
Timeframe: Baseline to Day 7

InterventionScore on a scale (Mean)
Loteprednol Etabonate and Tobramycin-11.03
Loteprednol Etabonate-10.94
Tobramycin-9.90
Vehicle-10.03

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Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2

Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. (NCT00705159)
Timeframe: Baseline to Day 3

InterventionScore on a scale (Mean)
Loteprednol Etabonate and Tobramycin-7.32
Loteprednol Etabonate-7.74
Tobramycin-5.94
Vehicle-6.58

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Change From Baseline in the Total Blepharoconjunctivitis Grade.

Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32. (NCT00705159)
Timeframe: Baseline to 15 days

InterventionScore on a scale (Mean)
Loteprednol Etabonate and Tobramycin-11.41
Loteprednol Etabonate-11.23
Tobramycin-10.68
Vehicle-10.30

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Mean Elevated Intraocular Pressure (IOP) During Treatment

Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days. (NCT00834171)
Timeframe: 55 days

InterventionMillimeters of mercury (mmHg) (Mean)
Loteprednol Etabonate Ophthalmic Suspension 0.5%24.8
Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)23.9

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Resolution of Anterior Chamber Cells (ACC).

Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp. (NCT01010633)
Timeframe: Visit 5 (Postoperative day 8)

InterventionEyes (Number)
Loteprednol62
Vehicle33

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Resolution of Anterior Chamber Cells.

Study eyes with complete resolution of anterior chamber cells (ACC) (NCT01010633)
Timeframe: At visits 4-7- postoperative day 3, 8,15 & 18

,
InterventionEyes (Number)
Visit 4Visit 5Visit 6Visit 7
Loteprednol176210296
Vehicle11334445

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Grade 0 Pain

Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants. (NCT01010633)
Timeframe: Visit 5 (Postoperative Day 8)

InterventionEyes (Number)
Loteprednol148
Vehicle85

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Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population

The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population. (NCT01028027)
Timeframe: Baseline, Day 3

InterventionScore on a scale (Mean)
Loteprednol and Tobramycin-5.54
Tobramycin and Dexamethasone-5.92

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Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population

The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population (NCT01028027)
Timeframe: Baseline, Day 8

InterventionScore on a scale (Mean)
Loteprednol and Tobramycin-8.91
Tobramycin and Dexamethasone-9.96

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Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population

The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. (NCT01028027)
Timeframe: Baseline, Day 8

InterventionScore on a scale (Mean)
Loteprednol and Tobramycin-9.20
Tobramycin and Dexamethasone-10.21

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Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population

The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population. (NCT01028027)
Timeframe: Baseline, Day 3

InterventionScore on a scale (Mean)
Loteprednol and Tobramycin-5.66
Tobramycin and Dexamethasone-5.98

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Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population

The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP). (NCT01028027)
Timeframe: Baseline, Day 15

InterventionScores on a scale (Mean)
Loteprednol and Tobramycin-11.63
Tobramycin and Dexamethasone-12.41

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Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population

The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population (NCT01028027)
Timeframe: Baseline, Day 15

InterventionScore on a scale (Mean)
Loteprednol and Tobramycin-11.64
Tobramycin and Dexamethasone-11.98

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Resolution of Anterior Chamber Cells.

Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells (NCT01060072)
Timeframe: Visit 5 (Postoperative day 8)

Interventionparticipants (Number)
Loteprednol Etabonate64
Vehicle28

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Grade 0 Pain

Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain (NCT01060072)
Timeframe: Visits 4-7 (Postoperative days 3-18)

,
Interventionparticipants (Number)
Visit 4 (Postoperative Day 3)Visit 5 (Postoperative Day 8)Visit 6 (Postoperative Day 15)Visit 7 (Postoperative Day 18)
Loteprednol Etabonate139156160151
Vehicle93928979

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Resolution of Anterior Chamber Cells

Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells (NCT01060072)
Timeframe: Visit 4-7 (postoperative day 3-18)

,
Interventionparticipants (Number)
Visit 4 (Postoperative Day 3)Visit 5 (Postoperative Day 8)Visit 6 (Postoperative Day 15)Visit 7 (Postoperative Day 18)
Loteprednol Etabonate864116114
Vehicle7286159

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Resolution of Anterior Chamber Flare

Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe. (NCT01060072)
Timeframe: Visit 4-7 (postoperative day 3-18)

,
Interventionparticipants (Number)
Visit 4 (Postoperative Day 3)Visit 5 (Postoperative Day 8)Visit 6 (Postoperative Day 15)Visit 7 (Postoperative Day 18)
Loteprednol Etabonate93134162143
Vehicle64729075

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Grade 0 Pain

Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain (NCT01060072)
Timeframe: Visit 5 (Postoperative day 8)

Interventionparticipants (Number)
Loteprednol Etabonate156
Vehicle92

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Conjunctival Redness

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. (NCT01107405)
Timeframe: Visit 4 (8 hr re-challenge)

,,,,
InterventionUnits on a scale (Mean)
7 min15 min20 min
Loteprednol Etabonate Base (BID)1.992.132.06
Loteprednol Etabonate Base (QD)1.761.952.02
Loteprednol Etabonate Base (QID)2.112.282.28
Loteprednol Etabonate Suspension (QID)2.162.182.16
Vehicle of Loteprednol Etabonate2.592.712.74

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Conjunctival Redness

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. (NCT01107405)
Timeframe: Visit 4 (initial challenge)

,,,,
Interventionunits on a scale (Mean)
7 min15 min20 min
Loteprednol Etabonate Base (BID)2.192.192.16
Loteprednol Etabonate Base (QD)1.962.052.15
Loteprednol Etabonate Base (QID)2.262.282.28
Loteprednol Etabonate Suspension (QID)2.222.362.29
Vehicle of Loteprednol Etabonate2.702.832.80

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Ocular Itching

Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. (NCT01107405)
Timeframe: Visit 4 (8 hr re-challenge)

,,,,
InterventionUnits on a Scale (Mean)
3 Min5 Min7 Min
Loteprednol Etabonate Base (QID)1.821.961.89
Loteprednol Etabonate Base (BID)1.842.132.03
Loteprednol Etabonate Base (QD)1.481.631.54
Loteprednol Etabonate Suspension (QID)1.932.122.04
Vehicle of Loteprednol Etabonate2.682.782.71

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Ocular Itching

Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. (NCT01107405)
Timeframe: Visit 4 (initial challenge)

,,,,
Interventionunits on a scale (Mean)
3 Min5 min7 min
Loteprednol Etabonate Base (BID)1.932.142.11
Loteprednol Etabonate Base (QD)2.022.192.11
Loteprednol Etabonate Base (QID)2.042.152.13
Loteprednol Etabonate Suspension (QID)2.172.322.22
Vehicle of Loteprednol Etabonate2.552.822.71

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Ocular Itching

Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. (NCT01107405)
Timeframe: Visit 3 (initial challenge)

,,,,
Interventionunits on a scale (Mean)
3 Min5 min7 min
Loteprednol Etabonate Base (QD)2.502.452.38
Loteprednol Etabonate Base (QID)2.312.462.21
Loteprednol Etabonate Suspension (QID)2.282.472.38
Vehicle of Loteprednol Etabonate2.502.632.45
Loteprednol Etabonate Base (BID)2.002.152.21

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Conjunctival Redness

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. (NCT01107405)
Timeframe: Visit 3 (initial challenge)

,,,,
Interventionunits on a scale (Mean)
7 min15 min20 min
Loteprednol Etabonate Base (BID)2.052.202.24
Loteprednol Etabonate Base (QD)2.142.262.31
Loteprednol Etabonate Base (QID)2.222.282.18
Loteprednol Etabonate Suspension (QID)2.252.432.33
Vehicle of Loteprednol Etabonate2.412.422.42

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Flare Scores in Early Postoperative Period

Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control. (NCT01344226)
Timeframe: baseline to 6 weeks

Interventionunits on a scale (Mean)
Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati0.08

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ETDRS Letters Read Over Early Postoperative Period

Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure. (NCT01344226)
Timeframe: change in ETDRS letters read baseline to 6 weeks

Interventionchange in ETDRS letters read (Mean)
Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati8.05

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Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.

Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation. (NCT01344226)
Timeframe: baseline to 6 weeks

Interventionmm Hg (Mean)
Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati-1.8

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Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification

Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome. (NCT01344226)
Timeframe: baseline to 6 weeks

Interventionunits on a scale (Mean)
Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati0.25

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Bulbar Conjunctival Injection

Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe (NCT01435460)
Timeframe: Change from baseline to day 15 (visit 3)

Interventionunits on a scale (Mean)
Alrex-1.91
Patanol-1.71

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Ocular Itching

Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe (NCT01435460)
Timeframe: Change from baseline to day 8 (visit 2)

Interventionunits on a scale (Mean)
Alrex-2.46
Patanol-2.02

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Ocular Itching

Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe (NCT01435460)
Timeframe: Change from baseline to day 15 (visit 3)

Interventionunits on a scale (Mean)
Alrex-3.74
Patanol-3.28

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Bulbar Conjunctival Injection

Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe (NCT01435460)
Timeframe: Change from baseline to day 8 (visit 2)

Interventionunits on a scale (Mean)
Alrex-1.36
Patanol-1.18

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Change From Baseline in Ocular Itching at 14 Days

Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point. (NCT01443442)
Timeframe: Change from Baseline in Ocular Itching at 14 Days

Interventionunits on a scale (Mean)
Bepreve2.17
Alrex1.82

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Corneal Fluorescein Staining Score

Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy. (NCT01456780)
Timeframe: Week 4 Time Point

Interventionunits on a scale (Mean)
Zylet6.3
Lotemax5.0
Bausch & Lomb Lubricant Drops4.8

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Ocular Surface Disease Index

OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT01456780)
Timeframe: Week 4 Time Point

Interventionunits on a scale (Mean)
Zylet56.6
Lotemax46.4
Bausch & Lomb Lubricant Drops48.4

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Symptom Assessment iN Dry Eye (SANDE) Frequency Score

Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms. (NCT01456780)
Timeframe: Week 4 Time Point

Interventionunits on a scale (Mean)
Zylet65.9
Lotemax51.7
Bausch & Lomb Lubricant Drops50.5

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Symptom Assessment iN Dry Eye (SANDE) Severity Score

Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms. (NCT01456780)
Timeframe: Week 4 Time Point

Interventionunits on a scale (Mean)
Zylet64.5
Lotemax54.4
Bausch & Lomb Lubricant Drops51.2

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Anterior Chamber Cells & Flare

"Anterior Chamber Flare (for those subjects that could be examined with a slit lamp):~Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect~= Mild Tyndall effect barely discernible~= Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly~= Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly~= Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance" (NCT01475643)
Timeframe: Over all visits 42 days

InterventionGrade of anterior chamber flare (Mean)
Loteprednol Etabonate.192
Prednisolones Acetate.341

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Anterior Chamber Inflammation

"Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal~= Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal~= Moderate Moderate anterior chamber clouding~= Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished~= Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished" (NCT01475643)
Timeframe: Postoperative Day 29

Interventiongrade of anterior chamber cells (Mean)
Loteprednol Etabonate.913
Prednisolones Acetate.783

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Progression of Dry Eye Severity

Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions. (NCT01695668)
Timeframe: 1 year

Interventionpatients with increased dry eye severity (Number)
Lotemax15
Restasis12

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Tear Fluid Levels

Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose (NCT01736527)
Timeframe: 9 hours

Interventionμg/g (Mean)
LE Gel19.667

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Tear Fluid Levels

Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose (NCT01736527)
Timeframe: 6 hours

Interventionμg/g (Mean)
LE Gel113.633

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Tear Fluid Levels

Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose (NCT01736527)
Timeframe: 12 hours

Interventionμg/g (Mean)
LE Gel26.877

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Tear Fluid Levels

Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose (NCT01736527)
Timeframe: 24 hours

Interventionμg/g (Mean)
LE Gel2.408

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Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12

"OSDI is a 12-item questionnaire developed to assess severity of DED. There are 3 question types: Have you experienced any of following (light sensitivity, eye feel gritty, sore eyes, blurred vision, and poor vision) during last week?(items 1-5); Have problems with your eyes limited you in performing any of following (reading, driving at night, working with computer, and watching TV) during last week? (items 6-9); and Have your eyes felt uncomfortable in any of following situations (windy, low humidity, air conditioned) during the last week? (items 10-12). Response of each of these questions were graded on a scale (that relate to the frequency of ocular surface disease effects) of 0 (none of the time) to 4 (all of the time).Total OSDI score was calculated using following formula: OSDI=([sum of scores for all questions answered] × 100)/([total number of questions answered] * 4). Total OSDI score ranged from 0 to 100, with higher scores representing greater disability." (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Light sensitivity: BaselineLight sensitivity: Change at Week 12Gritty feel: BaselineGritty feel: Change at Week 12Painful or sore eyes: BaselinePainful or sore eyes: Change at Week 12Blurred vision: BaselineBlurred vision: Change at Week 12Poor vision: BaselinePoor vision: Change at Week 12Problem in reading: BaselineProblem in reading: Change at Week 12Problem in driving at night: BaselineProblem in driving at night: Change at Week 12Problem in working with computer: BaselineProblem in working with computer:Change at Week12Problem in watching TV: BaselineProblem in watching TV: Change at Week 12Uncomfortable in windy conditions: BaselineUncomfortable in windy condition:Change at Week12Uncomfortable in low humidity: BaselineUncomfortable in low humidity: Change at Week 12Uncomfortable in air conditioning: BaselineUncomfortable in air conditioning:Change at Week12Total OSDI score: BaselineTotal OSDI score: Change at Week 12
Lotemax Gel 0.5%1.5-0.11.4-0.40.8-0.30.7-0.10.70.10.80.01.30.01.0-0.21.0-0.11.50.01.40.21.5-0.327.8-3.2
Lotemax Gel 0.5% and Restasis 0.05%1.5-0.21.5-0.51.0-0.20.9-0.20.8-0.10.70.00.9-0.20.9-0.10.9-0.41.3-0.21.5-0.71.5-0.327.9-5.6
Restasis 0.05%1.4-0.21.2-0.20.8-0.20.9-0.10.50.10.9-0.21.1-0.20.9-0.20.80.11.40.01.30.01.6-0.826.5-4.0

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Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12

"The TFBUT was defined as the interval between the last complete blink and the first appearance of dark zones or spots, or disruption in the tear film. Tear film breakup time is a measure of the stability of the tear film protecting the cornea and bulbar conjunctiva. 5 microliters (μL) of fluorescein solution was instilled in the participant's eye, after which the participant blinked several times, then kept the eye open. The cornea was visualized through the slit lamp using appropriate barrier filters for the white light source.~TFBUT was counted using a stopwatch. Three consecutive measurements were taken and averaged for actual TFBUT. TFBUT at Baseline (Day 0) was subtracted from TFBUT at Week 12 (Day 84) and reported as change. A higher number represented a lengthening in the TFBUT. A longer TFBUT indicated a more stable tear film." (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionseconds (Mean)
Study eye: BaselineStudy eye: Change at Week 12Both eyes: BaselineBoth eyes: Change at Week 12
Lotemax Gel 0.5%3.230.323.280.57
Lotemax Gel 0.5% and Restasis 0.05%2.870.253.010.17
Restasis 0.05%3.090.163.45-0.17

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Change From Baseline in Mean Tear Osmolarity Between Two Eyes of Participant at Week 12

Tear osmolarity was measured with the TearLab Osmolarity System. The TearLab instrument measures the impedance of 50 nL tear samples taken with a disposable lab-on-a-chip device. Tear samples from enrolled participants were taken at Weeks 2, 4, and 12 from each eye in duplicate with a tear sampler according to the manufacturer's instructions, and the tear osmolarity for each sample was read with the TearLab instrument. Osmolarity values were provided by the TearLab instrument in 3-digit units of mOsm. Change from mean baseline values for all participants within a treatment group was calculated for the difference between average values between 2 eyes at Week 12. (NCT01817582)
Timeframe: Baseline, Week 12

,,
InterventionmOsm (Mean)
BaselineChange at Week 12
Lotemax Gel 0.5%5.42.9
Lotemax Gel 0.5% and Restasis 0.05%7.90.6
Restasis 0.05%7.2-0.3

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Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12

Tear osmolarity was measured with the TearLab Osmolarity System. The TearLab instrument measures the impedance of 50 nanoliters (nL) tear samples taken with a disposable lab-on-a-chip device. Tear samples from enrolled participants were taken at Weeks 2, 4, and 12 from each eye in duplicate with a tear sampler according to the manufacturer's instructions, and the tear osmolarity for each sample was read with the TearLab instrument. Osmolarity values were provided by the TearLab instrument in 3-digit units of milliosmoles (mOsm). Change from mean baseline values for all participants within a treatment group was calculated using a participant's worst eye value at Week 12. (NCT01817582)
Timeframe: Baseline, Week 12

,,
InterventionmOsm (Mean)
BaselineChange at Week 12
Lotemax Gel 0.5%307.44.3
Lotemax Gel 0.5% and Restasis 0.05%312.10.7
Restasis 0.05%311.6-1.5

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Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12

LG staining is useful for monitoring evidence of eye dryness in conjunctival tissue. Scoring of conjunctival staining was done using Oxford conjunctival grading scale. The investigator instilled an ophthalmic dye (LG stain) on the eye and rated staining in 2 areas (nasal and temporal conjunctiva). Staining was rated on a 6-point scale from 0 (absent) to 5 (severe). The total score ranged from 0 (improvement; no conjunctival damage) to 12 (worsening; severe conjunctival damage). (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Score for study eye: BaselineScore for study eye: Change at Week 12Score for both eyes: BaselineScore for both eyes: Change at Week 12
Lotemax Gel 0.5%9.2-1.89.06-1.82
Lotemax Gel 0.5% and Restasis 0.05%8.5-0.98.37-0.98
Restasis 0.05%7.7-1.27.35-0.75

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Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12

Participants eligible for enrollment rated the severity of dry eye symptoms at Baseline (Day 0) on a 5-point grading scale (ranged from 0 [no problem] to 4 [continuous or severe discomfort; intolerable]) for each of 8 symptoms in the following symptom list prior to enrollment and then selected their most bothersome symptom: Photophobia, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, eye discomfort, burning or stinging, or photopsia (sensation of light or light flashes). Participants subsequently rated their dry eye symptom severity on the same 5-point grading scale at Week 2-Week 12 for study eye for the worst symptom identified at Baseline. (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Burning or stinging: BaselineBurning or stinging: Change at Week 12Eye discomfort: BaselineEye discomfort: Change at Week 12Foreign body sensation: BaselineForeign body sensation: Change at Week 12Grittiness or sandiness: BaselineGrittiness or sandiness: Change at Week 12Haziness or blurriness: BaselineHaziness or blurriness: Change at Week 12Itchiness or scratchiness: BaselineItchiness or scratchiness: Change at Week 12Photophobia: BaselinePhotophobia: Change at Week 12Photopsia: BaselinePhotopsia: Change at Week 12Worst dry eye symptom: BaselineWorst dry eye symptom: Change at Week 12
Lotemax Gel 0.5%1.2-0.61.8-0.91.3-0.61.6-0.81.2-0.31.5-0.61.4-0.20.3-0.12.6-1.3
Lotemax Gel 0.5% and Restasis 0.05%1.2-0.51.5-0.50.9-0.31.5-0.51.2-0.41.4-0.41.3-0.20.20.02.2-0.8
Restasis 0.05%1.0-0.31.8-1.11.0-0.51.3-0.51.3-0.61.5-0.51.5-0.50.3-0.12.5-1.5

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Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator

The objective redness scoring assessment was conducted by automated means using an Oculus Keratograph 5M. Duplicate digital photographs of bulbar and limbal conjunctiva were taken with the Oculus Keratograph 5M instrument for each eye of a participant and the images were analyzed using R-Scan classification software to numerically rate the severity of ocular redness (bulbar and limbal redness) on a 4-point (0-3) grading scale, where score 0 = none absent; no redness present in the white of the eyes, 1 = mild, slightly dilated blood vessels seen in some portion of white of the eyes; color of vessels was typically pink, 2 = moderate more apparent dilation of blood vessels in the white of the eyes; vessel color was more intense (redder) and involves the majority of the vessel bed, 3 = severe numerous obvious dilated blood vessels throughout the white of the eyes; the vessel color was deep red. Keratograph 5M ocular redness grading results were averaged for each eye and for both eyes. (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Limbal study eye redness: BaselineLimbal study eye redness: Change at Week 12Limbal both eyes redness: BaselineLimbal both eyes redness: Change at Week 12Bulbar study eye redness: BaselineBulbar study eye redness: Change at Week 12Bulbar both eyes redness: BaselineBulbar both eyes redness: Change at Week 12
Lotemax Gel 0.5%0.6150.0150.5500.0311.062-0.0690.992-0.038
Lotemax Gel 0.5% and Restasis 0.05%0.6080.0390.6430.0380.9750.1390.9950.064
Restasis 0.05%0.6250.0040.734-0.0500.965-0.0500.994-0.089

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Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator

The Investigator subjectively rated the degree of eye redness on a 4-point (0-3) grading scale prior to any objective grading of eye redness for a participant, where score 0 = none absent; no redness present in the white of the eyes, 1 = mild, slightly dilated blood vessels seen in some portion of the white of the eyes; the color of vessels was typically pink, 2 = moderate more apparent dilation of blood vessels in the white of the eyes; vessel color was more intense (redder) and involves the majority of the vessel bed, 3 = severe numerous obvious dilated blood vessels throughout the white of the eyes; the vessel color was deep red. (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Redness of study eye: BaselineRedness of study eye: Change at Week 12Redness of both eyes: BaselineRedness of both eyes: Change at Week 12
Lotemax Gel 0.5%1.0-0.20.97-0.21
Lotemax Gel 0.5% and Restasis 0.05%1.0-0.11.00-0.10
Restasis 0.05%1.0-0.11.06-0.12

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Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants

Participants and investigators independently rated the overall change from baseline in dry eye conditions for each participant on a 7-point Likert scale at Week 12. The scale ranged from +3 to -3, where +3 = Substantial improvement in dry eye; little or no awareness of dry eye, +2 = Some improvement in dry eye, +1 = Little improvement in dry eye, 0 = No improvement in dry eye, -1 = Slight worsening of dry eye, -2 = Some worsening of dry eye, and -3 = Substantial worsening of dry eye. (NCT01817582)
Timeframe: Baseline, Week 12

InterventionParticipants (Count of Participants)
Investigator-reported:71987905Investigator-reported:71987906Investigator-reported:71987904Participant-reported:71987905Participant-reported:71987906Participant-reported:71987904
+3+2+10-1-2-3
Lotemax Gel 0.5%2
Restasis 0.05%3
Lotemax Gel 0.5% and Restasis 0.05%7
Lotemax Gel 0.5%11
Restasis 0.05%10
Lotemax Gel 0.5% and Restasis 0.05%16
Lotemax Gel 0.5%12
Lotemax Gel 0.5% and Restasis 0.05%5
Lotemax Gel 0.5%8
Restasis 0.05%4
Lotemax Gel 0.5%1
Restasis 0.05%1
Lotemax Gel 0.5%0
Lotemax Gel 0.5% and Restasis 0.05%4
Lotemax Gel 0.5%6
Restasis 0.05%9
Lotemax Gel 0.5% and Restasis 0.05%10
Lotemax Gel 0.5%15
Restasis 0.05%14
Lotemax Gel 0.5% and Restasis 0.05%8
Lotemax Gel 0.5%7
Restasis 0.05%7
Lotemax Gel 0.5% and Restasis 0.05%6
Lotemax Gel 0.5%5
Restasis 0.05%2
Lotemax Gel 0.5% and Restasis 0.05%2
Lotemax Gel 0.5% and Restasis 0.05%0
Restasis 0.05%0
Lotemax Gel 0.5% and Restasis 0.05%1

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Averaged Daily Soothe Lubricant Eye Drops Usage

Amount of averaged daily soothe lubricant eye drops (Bausch + Lomb) used was reported. (NCT01817582)
Timeframe: Baseline up to Week 12

Interventiondrops/day (Mean)
Lotemax Gel 0.5% and Restasis 0.05%2.07
Lotemax Gel 0.5%1.79
Restasis 0.05%2.04

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Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4

Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the National Eye Institute (NEI) grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy). (NCT01817582)
Timeframe: Baseline (Day 0), Week 4

Interventionunits on a scale (Mean)
Lotemax Gel 0.5% and Restasis 0.05%-1.3
Lotemax Gel 0.5%-1.7
Restasis 0.05%-1.3

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Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4

"OSDI is a 12-item questionnaire developed to assess severity of DED. There are 3 question types: Have you experienced any of following (light sensitivity, eye feel gritty, sore eyes, blurred vision, and poor vision) during last week?(items 1-5); Have problems with your eyes limited you in performing any of following (reading, driving at night, working with computer, and watching TV) during last week? (items 6-9); and Have your eyes felt uncomfortable in any of following situations (windy, low humidity, air conditioned) during the last week? (items 10-12). Response of each of these questions were graded on a scale (that relate to the frequency of ocular surface disease effects) of 0 (none of the time) to 4 (all of the time).Total OSDI score was calculated using following formula: OSDI=([sum of scores for all questions answered] × 100)/([total number of questions answered] * 4). Total OSDI score ranged from 0 to 100, with higher scores representing greater disability." (NCT01817582)
Timeframe: Baseline, Week 4

Interventionunits on a scale (Mean)
Lotemax Gel 0.5% and Restasis 0.05%-5.2
Lotemax Gel 0.5%-1.3
Restasis 0.05%-0.6

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Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values

Participants scored their degree of comfort with their assigned study drug on a 4-point scale (0-3 units) within 5 minutes after instillation of study drug. Comfort grade 0 indicated comfortable, discomfort absent; 1 indicated generally comfortable, mild discomfort; 2 indicated some discomfort but tolerable, moderate discomfort; 3 indicated severely uncomfortable or intolerable. The mean global ocular comfort grade was reported. (NCT01817582)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Lotemax Gel 0.5% and Restasis 0.05%0.5
Lotemax Gel 0.5%0.6
Restasis 0.05%0.5

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Percentage of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01817582)
Timeframe: Baseline up to Week 13

Interventionpercentage of participants (Number)
Lotemax Gel 0.5% and Restasis 0.05%27.3
Lotemax Gel 0.5%25.0
Restasis 0.05%27.3

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Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13

Schirmer's test measures the aqueous component of tear secretion. The Schirmer's test (anesthetized) is a measure of the tonic secretion of the aqueous component of tears. A Schirmer's test (with anaesthesia) was performed for both eyes of a participant using Schirmer's test strips. After instillation of an ophthalmic anaesthetic, Schirmer's test strips for each eye were left in place for 5 minutes with participant eyelids closed. After 5 minutes, the Schirmer's test strips were removed with forceps and the distance to where each strip was wetted was recorded in millimeters (mm). Lesser wetting of strips (low levels of tear production) were associated with dry eye. (NCT01817582)
Timeframe: Baseline, Week 13

,,
Interventionmm (Mean)
Wetting distance for Study eye: BaselineWetting distance for Study eye: Change at Week 13Wetting distance for both eyes: BaselineWetting distance for both eyes: Change at Week 13
Lotemax Gel 0.5%6.61.76.781.39
Lotemax Gel 0.5% and Restasis 0.05%6.12.56.662.17
Restasis 0.05%6.62.56.762.59

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Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12

Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the NEI grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy). (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Score for study eye: BaselineScore for study eye: Change at Week 12Score for both eyes: BaselineScore for both eyes: Change at Week 12
Lotemax Gel 0.5%5.7-0.75.22-0.69
Lotemax Gel 0.5% and Restasis 0.05%5.6-1.35.02-0.66
Restasis 0.05%5.5-1.65.08-1.17

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Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12

An ocular comfort assessment questionnaire was administered at weeks 2, 4, and 12 to participants. The assessment of the degree of dry eye discomfort experienced by the participant was conducted using an adapted and validated 12-item ocular comfort questionnaire ( to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching) based upon the ocular comfort index of Johnson and Murphy. Each item (question) was graded from 0 to 4, where 0 = Not at all, 1 = Seldom; perceptible but not intense, 2 = Sometimes; intermittent with easily tolerable intensity, 3 = Frequently; often but with tolerable intensity, 4 = Constantly; constant or intolerable intensity. Total score was calculated and normalized to a score of 0 (no discomfort)-100 (more ocular discomfort) by the formula: Normalized comfort grade = ([Total Comfort Grade] * 100)/48. (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Dryness: BaselineDryness: Change at Week 12Dryness intensity: BaselineDryness intensity: Change at Week 12Grittiness: BaselineGrittiness: Change at Week 12Grittiness intensity: BaselineGrittiness intensity: Change at Week 12Stinging: BaselineStinging: Change at Week 12Stinging intensity: BaselineStinging intensity: Change at Week 12Tiredness: BaselineTiredness: Change at Week 12Tiredness intensity: BaselineTiredness intensity: Change at Week 12Pain: BaselinePain: Change at Week 12Pain intensity: BaselinePain intensity: Change at Week 12Itch: BaselineItch: Change at Week 12Itch intensity: BaselineItch intensity: Change at Week 12Total comfort score: BaselineTotal comfort score: Change at Week 12
Lotemax Gel 0.5%2.2-0.12.1-0.31.7-0.61.6-0.61.2-0.41.3-0.41.6-0.21.6-0.20.8-0.20.8-0.31.6-0.71.5-0.737.8-10.0
Lotemax Gel 0.5% and Restasis 0.05%2.3-0.42.2-0.51.5-0.41.6-0.51.3-0.21.2-0.21.8-0.41.7-0.30.9-0.20.9-0.11.5-0.21.5-0.238.4-7.2
Restasis 0.05%2.2-0.42.2-0.61.4-0.61.3-0.51.0-0.11.0-0.11.9-0.41.8-0.40.7-0.20.8-0.31.2-0.21.2-0.334.8-8.6

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Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12

The 5-item Dry Eye Questionnaire (DEQ-5) is a validated questionnaire for discriminating self-assessed severity of dry eye diagnoses. The participants rated the frequency on a scale of 0 (never) to 4 (constant) with which they have experienced 3 symptoms (watery eyes, discomfort and dryness). The participant was also asked to rate the increase in intensity of discomfort and dryness throughout the day on a scale of 0 (never have it) to 5 (very intense). Participant rated the overall severity of dry eye symptoms on a scale of 0 (no problem) to 4 (intolerable; unable to perform my daily tasks). Total DEQ-5 score was the sum of scores for frequency and intensity of dryness and discomfort plus frequency of watery eyes. A DEQ-5 total score >6 was indicative of DED and a score >12 is indicative of Sjögren's syndrome. (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Mean)
Discomfort frequency: BaselineDiscomfort frequency: Change at Week 12Discomfort intensity: BaselineDiscomfort intensity: Change at Week 12Dryness frequency: BaselineDryness frequency: Change at Week 12Dryness intensity: BaselineDryness intensity: Change at Week 12Watery eyes frequency: BaselineWatery eyes frequency: Change at Week 12Overall severity: BaselineOverall severity: Change at Week 12Total score: BaselineTotal score: Change at Week 12
Lotemax Gel 0.5%2.1-0.22.5-0.52.1-0.12.8-0.71.3-0.41.8-0.410.8-2.0
Lotemax Gel 0.5% and Restasis 0.05%2.2-0.42.4-0.42.4-0.62.4-0.21.5-0.41.9-0.611.0-2.0
Restasis 0.05%2.1-0.32.4-0.42.4-0.62.3-0.41.30.01.8-0.510.6-1.6

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Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12

The tear film breakup time was defined as the interval between the last complete blink and the first appearance of dark zones or spots, or disruption in the tear film. Tear film examination using any non-invasive method analyzes optical reflections from the cornea. Reflections that become distorted are characteristic of tear film breakup. Circular images were projected onto the corneal surface using an Oculus Keratograph 5M instrument, and the tear film reflection was observed on a computer. NIKBUT (initial break-up time [NIKBUTi] and average break-up time [NIKBUTav]) were determined and recorded for each eye in duplicate after participant blink 2 times. NIKBUT at Baseline (Day 0) was subtracted from NIKBUT at Week 12 (Day 84) and reported as change. A higher number represented a lengthening in the NIKBUT. A longer NIKBUT indicated a more stable tear film. (NCT01817582)
Timeframe: Baseline, Week 12

,,
Interventionseconds (Mean)
NIKBUTi for study eye: BaselineNIKBUTi for study eye: Change at Week 12NIKBUTi for both eyes: BaselineNIKBUTi for both eyes: Change at Wee 12NIKBUTav for study eye: BaselineNIKBUTav for study eye: Change at Week 12NIKBUTav for both eyes: BaselineNIKBUTav for both eyes: Change at Week 12
Lotemax Gel 0.5%8.111.098.220.1711.201.5510.991.32
Lotemax Gel 0.5% and Restasis 0.05%6.490.596.92-0.149.57-0.019.21-0.04
Restasis 0.05%7.180.317.60-1.089.071.269.980.04

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Intraocular Pressure

Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading. (NCT01853696)
Timeframe: from 1 to 12 months after transplant

Interventioneyes (Number)
Loteprednol11
Prednisolone Acetate27

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Immunologic Graft Rejection Episode

Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination. (NCT01853696)
Timeframe: within first year after cornea transplantation

Interventioneyes (Number)
Loteprednol0
Prednisolone Acetate0

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. (NCT01996839)
Timeframe: 8 days

InterventionParticipants (Count of Participants)
Vehicle (BID and TID)16
Loteprednol Etabonate Gel (BID)46
Loteprednol Etabonate Gel (TID)49

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Percentage of Participants With Grade 0 Pain in the Study Eye.

Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe. (NCT01996839)
Timeframe: 8 days

InterventionParticipants (Count of Participants)
Vehicle (BID and TID)82
Loteprednol Etabonate Gel (BID)126
Loteprednol Etabonate Gel (TID)125

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). (NCT01996839)
Timeframe: 18 days

,,
InterventionParticipants (Count of Participants)
Day 3Day 8Day 15Day 18
Loteprednol Etabonate Gel (BID)12457374
Loteprednol Etabonate Gel (TID)7478390
Vehicle (BID and TID)11162740

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. (NCT01996839)
Timeframe: 18 days

,,
InterventionParticipants (Count of Participants)
Day 3Day 15Day 18
Loteprednol Etabonate Gel (BID)137377
Loteprednol Etabonate Gel (TID)78391
Vehicle (BID and TID)122840

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.

Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0. (NCT01996839)
Timeframe: 18 days

,,
InterventionParticipants (Count of Participants)
Day 3Day 8Day 15Day 18
Loteprednol Etabonate Gel (BID)95117124115
Loteprednol Etabonate Gel (TID)90122131127
Vehicle (BID and TID)78717168

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Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. (NCT01996839)
Timeframe: 18 days

,,
InterventionParticipants (Count of Participants)
Day 3Day 15Day 18
Loteprednol Etabonate Gel (BID)123129122
Loteprednol Etabonate Gel (TID)117137122
Vehicle (BID and TID)968173

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Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire

Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome (NCT02120079)
Timeframe: 6 Weeks

InterventionScore (Mean)
Lotemax46.63
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)36.04

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Ocular Signs: Schirmer's Test With Anesthesia

The Schirmer's Test (performed using Anesthesia) will be measured in mm. (NCT02120079)
Timeframe: 6 Weeks

Interventionmm (Mean)
Lotemax8.16
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)8.18

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Ocular Signs: Schirmer's Test With Anesthesia

The Schirmer's Test (performed using Anesthesia) will be measured in mm. (NCT02120079)
Timeframe: 2 Weeks

Interventionmm (Mean)
Lotemax7.98
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)6.88

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Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry

Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg (NCT02120079)
Timeframe: 6 Weeks

InterventionmmHg (Mean)
Lotemax16.88
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)13.76

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Ocular Signs: Tear Break Up Time (TBUT)

Tear Break Up Time (TBUT) will be recorded in seconds (NCT02120079)
Timeframe: 2 Weeks

InterventionSeconds (Mean)
Lotemax5.20
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)3.93

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IVCM for Density of Corneal Immune Dendritiform Cells

Density (in cells/mm2) of Corneal Immune Dendritiform Cells (NCT02120079)
Timeframe: 2 Weeks

Interventioncells/mm2 (Mean)
Lotemax9.47
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)28.60

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Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry

Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg (NCT02120079)
Timeframe: 2 Weeks

InterventionmmHg (Mean)
Lotemax15.52
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)14.50

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Ocular Signs: Corneal Epitheliopathy

Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome (NCT02120079)
Timeframe: 6 Weeks

InterventionScore (Mean)
Lotemax2.00
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)3.59

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Ocular Signs: Corneal Epitheliopathy

Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome (NCT02120079)
Timeframe: 2 Weeks

InterventionScore (Mean)
Lotemax1.86
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)3.18

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Ocular Signs: Conjunctival Epitheliopathy

Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome (NCT02120079)
Timeframe: 6 Weeks

InterventionScore (Mean)
Lotemax2.46
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)3.44

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IVCM for Density of Corneal Immune Dendritiform Cells

Density (in cells/mm2) of corneal immune dendritiform cells (NCT02120079)
Timeframe: 6 Weeks

Interventioncells/mm2 (Mean)
Lotemax9.80
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)34.03

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IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

Morphology (in cells/mm2) of Corneal Immune Dendritiform Cells (NCT02120079)
Timeframe: 2 Weeks

Interventioncells/mm2 (Mean)
Lotemax109.50
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)97.95

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IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

Morphology (in cells.mm2) of Corneal Immune Dendritiform Cells (NCT02120079)
Timeframe: 6 Weeks

InterventionCells/mm2 (Mean)
Lotemax102.31
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)89.34

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Ocular Signs: Conjunctival Epitheliopathy

Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome (NCT02120079)
Timeframe: 2 Weeks

InterventionScore (Mean)
Lotemax3.79
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)4.50

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Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire

Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome (NCT02120079)
Timeframe: 2 Weeks

InterventionScore (Mean)
Lotemax47.25
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)33.16

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Ocular Signs: Tear Break Up Time (TBUT)

Tear Break Up Time (TBUT) will be recorded in seconds (NCT02120079)
Timeframe: 6 Weeks

InterventionSeconds (Mean)
Lotemax4.83
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)3.44

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Anterior Chamber Cell Grade at Visit 6.

"Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 6/Day 15. The difference in mean grade of AC cell count grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~1 - 5 cells~6 - 15 cells~16 - 30 cells 4 = greater than 30 cells" (NCT02163824)
Timeframe: Visit 6 (postoperative day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% QID0.4
KPI-121 1.0% BID0.5
Vehicle of KPI-1210.6

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Ocular Pain Grades at Day 15.

"Mean Grade of Ocular Pain (Scale 0-5) at Visit 6/Day 15. The difference in mean grade of ocular pain grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain.~Higher scores were worse outcomes.~The following scoring scale was used for ocular pain:~0 = None~Minimal~Mild~Moderate~Moderately Severe~Severe" (NCT02163824)
Timeframe: Visit 6 (postoperative day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% QID0.2
KPI-121 1.0% BID0.2
Vehicle of KPI-1210.3

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Ocular Pain Grades at Day 8.

"Mean Grade of Ocular Pain (Scale 0-5) at Visit 5/Day 8. The difference in mean grade of ocular pain grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain. Higher scores were worse outcomes.~The following scoring scale was used for ocular pain:~0 = None~Minimal~Mild~Moderate~Moderately Severe~Severe" (NCT02163824)
Timeframe: Visit 5 (postoperative day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% QID0.4
KPI-121 1.0% BID0.4
Vehicle of KPI-1210.5

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Resolution of Anterior Chamber Cells

"Subjects with complete resolution of anterior chamber cells (cell score = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6.~0= No cells seen~1 to 5 cells~6 to 15 cells~16 to 30 cells~greater than 30 cells" (NCT02163824)
Timeframe: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

InterventionParticipants (Count of Participants)
KPI-121 0.25% QID48
KPI-121 1.0% BID39
Vehicle of KPI-12119

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Resolution of Ocular Pain

Subjects with complete resolution of pain (grade = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6. (NCT02163824)
Timeframe: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

InterventionParticipants (Count of Participants)
KPI-121 0.25% QID73
KPI-121 1.0% BID67
Vehicle of KPI-12143

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Anterior Chamber Cell Grade at Visit 5.

"Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 5/Day 8. The difference in mean grade of AC cell count grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~1 - 5 cells~6 - 15 cells~16 - 30 cells 4 = greater than 30 cells" (NCT02163824)
Timeframe: Visit 5 (postoperative day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% QID0.7
KPI-121 1.0% BID0.9
Vehicle of KPI-1211.0

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Corneal Fluorescein Staining Scores

Comparison of mean corneal fluorescein staining scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. The total score is obtained by summing each of the 5 sections of the cornea. The NEI score will be from 0-15. (NCT02188160)
Timeframe: Visit 4 (Day 15) and Visit 6 (Day 29)

,
Interventionscore on a scale (Mean)
Visit 4 (Day 15)Visit 6 (Day 29)
KPI-121 0.25% Ophthalmic Suspension6.155.64
Vehicle7.006.16

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Bulbar Conjunctival Hyperemia

Comparison of mean bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02188160)
Timeframe: Visit 6 (Day 29)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension1.22
Vehicle1.36

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Bulbar Conjunctival Hyperemia Scores

Comparison of mean bulbar conjunctival hyperemia scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02188160)
Timeframe: Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension1.36
Vehicle1.42

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Ocular Discomfort

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02188160)
Timeframe: Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension58.83
Vehicle63.63

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Ocular Discomfort

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02188160)
Timeframe: Visit 6 (Day 29)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension57.05
Vehicle60.47

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. (NCT02208297)
Timeframe: 8 days

InterventionParticipants (Count of Participants)
Loteprednol Etabonate Gel (BID)38
Vehicle Gel (BID)29

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Percentage of Participants With Grade 0 Pain in the Study Eye.

Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe. (NCT02208297)
Timeframe: 8 days

InterventionParticipants (Count of Participants)
Loteprednol Etabonate Gel (BID)120
Vehicle Gel (BID)97

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). (NCT02208297)
Timeframe: 18 days

,
InterventionParticipants (Count of Participants)
Day 3Day 8Day 15Day 18
Loteprednol Etabonate Gel (BID)15378080
Vehicle Gel (BID)9295667

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Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. (NCT02208297)
Timeframe: 18 days

,
InterventionParticipants (Count of Participants)
Day 8Day 15Day 18
Loteprednol Etabonate Gel (BID)106132122
Vehicle Gel (BID)879591

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.

Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0. (NCT02208297)
Timeframe: 18 days

,
InterventionParticipants (Count of Participants)
Day 1Day 8Day 15Day 18
Loteprednol Etabonate Gel (BID)96114131128
Vehicle Gel (BID)718110098

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Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit

White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. (NCT02208297)
Timeframe: 18 days

,
InterventionParticipants (Count of Participants)
Day 3Day 15Day 18
Loteprednol Etabonate Gel (BID)168280
Vehicle Gel (BID)115767

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Change From Baseline in Ocular Discomfort

Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 4 (Day 15). (NCT02218489)
Timeframe: Visit 2 (Day 1) to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
Vehicle-4.1
KPI-121 0.25% Ophthalmic Suspension-2.4

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Change From Baseline in Ocular Discomfort

Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 6 (Day 29). (NCT02218489)
Timeframe: Visit 2 (Day 1) to Visit 6 (Day 29)

Interventionscore on a scale (Mean)
Vehicle-8.2
KPI-121 0.25% Ophthalmic Suspension-5.0

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Change From Baseline in Posterior Lid Margin Hyperemia

"Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:~0=normal~mild~moderate~severe~very severe" (NCT02218489)
Timeframe: Visit 2 (Day 1) to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
Vehicle-0.56
KPI-121 0.25% Ophthalmic Suspension-0.55

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Change From Baseline in Posterior Lid Margin Hyperemia

"Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:~0=normal~mild~moderate~severe~very severe" (NCT02218489)
Timeframe: Visit 2 (Day 1) to Visit 6 (Day 29)

Interventionscore on a scale (Mean)
Vehicle-0.63
KPI-121 0.25% Ophthalmic Suspension-0.65

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Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline

"Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:~0=normal~mild~moderate~severe~very severe" (NCT02218489)
Timeframe: Visit 2 (Day 1) to Visit 6 (Day 29)

Interventionscore on a scale (Mean)
Vehicle-0.4
KPI-121 0.25% Ophthalmic Suspension-0.6

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Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline

"Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description:~0=normal~mild~moderate~severe~very severe" (NCT02218489)
Timeframe: Visit 2 (Day 1) to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
Vehicle-0.5
KPI-121 0.25% Ophthalmic Suspension-04

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Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)

Best Corrected Visual Acuity (BCVA) was measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. More letters read correctly results in a higher letter score, which represents better visual acuity. (NCT02245516)
Timeframe: Day 1 to Day 57

InterventionETDRS letters (Mean)
KPI-121 1.0% Ophthalmic Suspension-0.9
KPI-121 0.25% Ophthalmic Suspension-2.0

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Macular Volume by SD-OCT

Change in measurement (in microns) in macular volume as measured by Spectral Domain Optical Coherence Tomography (OCT) (NCT02245516)
Timeframe: Day 1 to Day 57

Interventionmm^3 (Mean)
KPI-121 1.0% Ophthalmic Suspension-0.237
KPI-121 0.25% Ophthalmic Suspension-0.377

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Center Subfield Retinal Thickness by SD-OCT

Change in measurement (in microns) in the central subfield retinal thickness as measured by Spectral Domain Optical Coherence Tomography (OCT) (NCT02245516)
Timeframe: Day 1 to Day 57

Interventionmicrometers (μm) (Mean)
KPI-121 1.0% Ophthalmic Suspension-8.2
KPI-121 0.25% Ophthalmic Suspension4.8

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Visual Quality

Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes. (NCT02322528)
Timeframe: baseline, 30 minutes, week 1, week 2

Interventionmicrons (Mean)
baseline30 minutesweek 1week 2
Administration of 0.5% Lotemax0.480.540.490.48

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Ocular Surface Temperature of Both Eyes

Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays. (NCT02322528)
Timeframe: baseline, 30 minutes, week 1, week 2

Interventiondegrees celcius (Mean)
baseline30 minutesweek 1week 2
Administration of 0.5% Lotemax33.9534.333.9333.95

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Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit

Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). The combined endpoint was defined as the sum of the scores for AC cells and AC flare. Summed Anterior Chamber (AC) Cell and Flare Scores could range from 0 to 8. (NCT02786901)
Timeframe: 14 days

Interventionscore on a scale (Mean)
Vehicle BID and TID-1.2
LE Gel BID-2.0
LE Gel TID-2.1

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Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)

Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. (NCT02786901)
Timeframe: 8 days

InterventionParticipants (Count of Participants)
Vehicle BID and TID40
LE Gel BID52
LE Gel TID61

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Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit.

Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. (NCT02786901)
Timeframe: 14 days

InterventionParticipants (Count of Participants)
Vehicle BID and TID67
LE Gel BID82
LE Gel TID94

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Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit

Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution. (NCT02786901)
Timeframe: 14 days

InterventionParticipants (Count of Participants)
Vehicle BID and TID107
LE Gel BID143
LE Gel TID153

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Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit

Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution. (NCT02786901)
Timeframe: 14 days

InterventionParticipants (Count of Participants)
Vehicle BID and TID66
LE Gel BID82
LE Gel TID92

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Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit

Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0. (NCT02786901)
Timeframe: 14 days

InterventionParticipants (Count of Participants)
Vehicle BID and TID122
LE Gel BID168
LE Gel TID170

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Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)

Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0. (NCT02786901)
Timeframe: 8 days

InterventionParticipants (Count of Participants)
Vehicle BID and TID99
LE Gel BID151
LE Gel TID151

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Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8)

A participant was considered a treatment failure at Visit 5 if they started any rescue medication prior to, or on the day of, Visit 5. If a subject did not have a Visit 5, due either to early discontinuation or to a missed visit, then treatment failure at Visit 5 was defined as starting rescue medication prior to, or on, Postoperative Day 8. (NCT02786901)
Timeframe: 8 days

InterventionParticipants (Count of Participants)
Vehicle BID and TID62
LE Gel BID23
LE Gel TID20

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Complete Resolution of Anterior Chamber (AC) Cells at Day 8

"Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells" (NCT02793817)
Timeframe: Visit 5 (Day 8) maintained through Visit 6 (Day 15)

InterventionParticipants (Count of Participants)
KPI-121 1% Ophthalmic Suspension54
Vehicle of KPI-121 1% Ophthalmic Suspension32

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Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 8

"The difference in mean changes from BL in AC cell count grade at Day 8 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells" (NCT02793817)
Timeframe: Visit 1 (Baseline) and Visit 5 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 1% Ophthalmic Suspension-1.3
Vehicle of KPI-121 1% Ophthalmic Suspension-1.0

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Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4

"The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells" (NCT02793817)
Timeframe: Visit 1 (Baseline) and Visit 4 (Day 4)

Interventionscore on a scale (Mean)
KPI-121 1% Ophthalmic Suspension-0.7
Vehicle of KPI-121 1% Ophthalmic Suspension-0.5

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Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 15

"The difference in mean changes from BL in AC cell count grade at Day 15 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells" (NCT02793817)
Timeframe: Visit 1 (Baseline) and Visit 6 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 1% Ophthalmic Suspension-1.8
Vehicle of KPI-121 1% Ophthalmic Suspension-1.6

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Complete Resolution of Ocular Pain at Day 8

"Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes.~The following scoring scale was used for ocular pain:~0 = None~= Minimal~= Mild~= Moderate~= Moderately Severe~= Severe" (NCT02793817)
Timeframe: Visit 5 (Day 8) maintained through Visit 6 (Day 15)

InterventionParticipants (Count of Participants)
KPI-121 1% Ophthalmic Suspension149
Vehicle of KPI-121 1% Ophthalmic Suspension96

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Complete Resolution of Ocular Pain at Day 4

"Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes.~The following scoring scale was used for ocular pain:~0 = None~= Minimal~= Mild~= Moderate~= Moderately Severe~= Severe" (NCT02793817)
Timeframe: Visit 4 (Day 4) maintained through Visit 6 (Day 15)

InterventionParticipants (Count of Participants)
KPI-121 1% Ophthalmic Suspension109
Vehicle of KPI-121 1% Ophthalmic Suspension64

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Complete Resolution of Anterior Chamber (AC) Flare at Day 4

"Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better.~Anterior Chamber Flare 0 = None~= Mild (trace to clearly noticeable, visible)~= Moderate (without plastic aqueous humor)~= Marked (with plastic aqueous humor)~= Severe (with fibrin deposits and/or clots)" (NCT02793817)
Timeframe: Visit 4 (Day 4) maintained through Visit 6 (Day 15)

InterventionParticipants (Count of Participants)
KPI-121 1% Ophthalmic Suspension113
Vehicle of KPI-121 1% Ophthalmic Suspension63

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Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-8.12
Vehicle of KPI-121 0.25% Ophthalmic Suspension-4.81

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Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)

Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

InterventionParticipants (Count of Participants)
KPI-121 0.25% Ophthalmic Suspension189
Vehicle of KPI-121 0.25% Ophthalmic Suspension98

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Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)

Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe (NCT02813265)
Timeframe: Visit 4 (Day 15)

InterventionParticipants (Count of Participants)
KPI-121 0.25% Ophthalmic Suspension27
Vehicle of KPI-121 0.25% Ophthalmic Suspension16

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Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-6.60
Vehicle of KPI-121 0.25% Ophthalmic Suspension-3.20

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Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)

Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.4648
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.2045

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Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)

Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.2980
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.0421

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Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-9.90
Vehicle of KPI-121 0.25% Ophthalmic Suspension-6.38

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Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-16.67
Vehicle of KPI-121 0.25% Ophthalmic Suspension-10.76

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Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-14.53
Vehicle of KPI-121 0.25% Ophthalmic Suspension-9.16

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Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)

Comparison of mean corneal fluorescein staining between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.5
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.4

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Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort

Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale in a sub-group of participants with more severe ocular discomfort at baseline.. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.47
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.22

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Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)

Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.4049
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.1574

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Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline. (NCT02813265)
Timeframe: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-8.48
Vehicle of KPI-121 0.25% Ophthalmic Suspension-5.20

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Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4

Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Day 4

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-5.09
Vehicle of KPI-121 0.25% Ophthalmic Suspension-4.10

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Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)

Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-5.96
Vehicle of KPI-121 0.25% Ophthalmic Suspension-4.42

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Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)

Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Day 3

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-3.28
Vehicle of KPI-121 0.25% Ophthalmic Suspension-3.15

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Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)

Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-11.14
Vehicle of KPI-121 0.25% Ophthalmic Suspension-9.24

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Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)

Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-10.20
Vehicle of KPI-121 0.25% Ophthalmic Suspension-8.38

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Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)

Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.6
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.4

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Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)

Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.6
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.5

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Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)

Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-14.0
Vehicle of KPI-121 0.25% Ophthalmic Suspension-11.5

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Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)

Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-9.6
Vehicle of KPI-121 0.25% Ophthalmic Suspension-8.0

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Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)

Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-0.3812
Vehicle of KPI-121 0.25% Ophthalmic Suspension-0.2371

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Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)

Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Day 1

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-2.33
Vehicle of KPI-121 0.25% Ophthalmic Suspension-2.43

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Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)

Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

InterventionParticipants (Count of Participants)
KPI-121 0.25% Ophthalmic Suspension171
Vehicle of KPI-121 0.25% Ophthalmic Suspension127

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Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)

Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-6.92
Vehicle of KPI-121 0.25% Ophthalmic Suspension-4.86

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Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup

Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means. (NCT02819284)
Timeframe: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Interventionscore on a scale (Mean)
KPI-121 0.25% Ophthalmic Suspension-12.45
Vehicle of KPI-121 0.25% Ophthalmic Suspension-9.45

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Best Corrected Visual Acuity at 3 Months

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.120
Prednisolone Acetate 1% Oph Susp-0.114

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Number of Eyes With Corneal Haze

As determined by slit lamp examination (NCT03123614)
Timeframe: 12 months

InterventionEyes (Count of Units)
Loteprednol Etabonate 0.5% Oph Gel3
Prednisolone Acetate 1% Oph Susp7

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Uncorrected Visual Acuity

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.078
Prednisolone Acetate 1% Oph Susp-0.075

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Change in Intraocular Pressure (IOP) From Baseline Through Month 3

Intraocular pressure will be measured by applanation tonometry (NCT03123614)
Timeframe: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op

,
InterventionmmHg (Mean)
Baseline intraocular pressure (IOP)IOP 1 week postopIOP 1 month postopIOP 2 months postopIOP 3 months postop
Loteprednol Etabonate 0.5% Oph Gel14.3813.6714.1513.3613.15
Prednisolone Acetate 1% Oph Susp14.3013.2814.6013.1612.22

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Mean Ocular Surface Staining From Baseline

"The primary outcome measure was the mean corneal surface staining (guided by use of fluorescein and lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.~Corneal fluorescein staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in five regions of the cornea and summed for a total score of 0-15." (NCT04555694)
Timeframe: Baseline to Week 4, Week 8 and Week 12

,,
InterventionScore on a scale (Mean)
BaselineWeek 4Week 8Week 12
Restasis0.51.10.30.5
Restasis and Dextenza0.60.60.50.7
Restasis and Lotemax0.80.90.00.6

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Mean Conjunctival Staining

"The mean conjunctival staining (guided by use of lissamine green) at weeks 4, 8 and 12 from baseline based on the National Eye Institute grading scale.~Conjunctival staining was scored from 0 to 3 on the scale (none, better to heavy, worse) in six regions of the cornea and summed for a total score of 0-18." (NCT04555694)
Timeframe: Baseline to Week 4, Week 8 and Week 12

,,
InterventionScore on a scale (Mean)
BaselineWeek 4Week 8Week 12
Restasis0.40.50.30.7
Restasis and Dextenza0.50.30.40.8
Restasis and Lotemax1.50.90.81.0

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DEQ-5 Score

Dry Eye Questionnaire-5 (5 questions about dry eye symptoms rated from 0, or never to 5, or constantly) total score of 0-22 with higher scores representing worse symptoms at weeks 4, 8 and 12 from baseline (NCT04555694)
Timeframe: Baseline to Week 4, Week 8 and Week 12

,,
InterventionScore on a scale (Mean)
BaselineWeek 4Week 8Week 12
Restasis14.412.210.69.4
Restasis and Dextenza14.110.611.310.3
Restasis and Lotemax14.411.09.110.2

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Tear Breakup Time (Seconds)

The time it takes (in seconds) for the tear film to break after blinking at Week 4, 8 and 12 from Baseline (NCT04555694)
Timeframe: Baseline to Week 4, Week 8 and Week 12

,,
InterventionSeconds (Mean)
BaslineWeek 4Week 8Week 12
Restasis5.77.47.17.3
Restasis and Dextenza6.68.07.77.7
Restasis and Lotemax5.46.16.26.1

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Tear Osmolarity

"Tear osmolarity as measured by TearLab (275-307 is considered homeostatic range) at Week 4, 8 and 12 from Baseline." (NCT04555694)
Timeframe: Baseline to Week 4, Week 8 and Week 12

,,
InterventionmOsM/L (Mean)
BaselineWeek 4Week 8Week 12
Restasis306.9307.9295.3304.6
Restasis and Dextenza295.5304.4303.9299.5
Restasis and Lotemax311.3307.7300.1304.4

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Meibomian Gland Scores

Meibomian gland scoring on a scale of 1-4 (1 represents clear, liquid secretions and 4 is no secretions) in three regions (nasal, central, temporal) and summed for a single score between 3-12 at Week 4, 8 and 12 from baseline (NCT04555694)
Timeframe: Baseline to Week 4, Week 8 and Week 12

,,
InterventionScore on a scale (Mean)
BaselineWeek 4Week 8Week 12
Restasis9.27.28.27.3
Restasis and Dextenza8.77.68.38.7
Restasis and Lotemax7.16.76.36.0

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Mean Schirmer Tear Test 1 Score

Schirmer Tear Test 1 score, measuring tear production, as measured by a Schirmer's test strip with anesthetic (mm/5min on a strip 0-35mm. 0 mm is worse, >15 indicates normal production) at week 4, 8 and 12 from Baseline. (NCT04555694)
Timeframe: Baseline to Week 4, Week 8 and Week 12

,,
InterventionScore on a scale (Mean)
BaselineWeek 4Week 8Week 12
Restasis11.610.110.89.6
Restasis and Dextenza14.915.415.812.3
Restasis and Lotemax10.312.912.410.1

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