Loteprednol Etabonate
FDA-approved product (suspension/drops, ophthalmic), marketed as Alrex, Eysuvis, Inveltys and 3 more.
- Registered studies
- 50+
- Lab records
- 0
- Pathogens at ≥40%
- 1 of 4
Chemical structure
Existing / approved use
Documented · FDA, WHO, ChEMBLApproved for
- Allergic conjunctivitis
- Anterior uveitis
- Dry eye syndrome
- Eye inflammation
- Inflammation
Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗
- WHO therapeutic group
- Corticosteroids, plain
- Anti-infective classification
- Not classified as an anti-infective.
Repurposing investigation
This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA. It was surfaced computationally for further investigation; it is not an established treatment for this infection.
AI-predicted activity
AI prediction · nothing measured- MRSA53.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
- E. coli39.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
- K. pneumoniae23.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
- M. tuberculosis34.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.
Evidence
Clinical and experimental
Documented evidenceClinical
50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.
Experimental
No evidence found
No laboratory measurement against the four pathogens in the ChEMBL records loaded here.
Docking
Computational · nothing measuredAutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.
Other medicines to investigate
AI prediction · nothing measuredOther repurposing candidates: approved medicines besides Loteprednol Etabonate with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.
Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.
- Folic AcidExisting use: Acne, Anemia, Anemia (phenotype) and 8 more47.8% AI-predicted activityagainst K. pneumoniae50+ registered studies
- Pafolacianine SodiumExisting use: Other diagnostic agents47.8% AI-predicted activityagainst K. pneumoniae1 registered study
- Rezafungin AcetateExisting use: Candidemia, Candidiasis, Candidiasis, Invasive47.6% AI-predicted activityagainst K. pneumoniae5 registered studies
- Simeprevir SodiumExisting use: Chronic hepatitis C virus infection47.3% AI-predicted activityagainst K. pneumoniaeNo documented evidence found
- Ergoloid MesylatesExisting use: Cardiovascular disease47.1% AI-predicted activityagainst K. pneumoniae2 registered studies
- TrabectedinExisting use: Cancer, Dedifferentiated liposarcoma, Leiomyosarcoma and 7 more47.1% AI-predicted activityagainst K. pneumoniae50+ registered studies
- LurbinectedinExisting use: Cancer, Neoplasm, Small cell lung carcinoma47.0% AI-predicted activityagainst K. pneumoniae50+ registered studies
- EptifibatideExisting use: Acute coronary syndrome, Acute myocardial infarction, Intermediate coronary syndrome and 2 more46.7% AI-predicted activityagainst K. pneumoniae35 registered studies
- Hydrocodone BitartrateExisting use: Cough, Drug dependence, Pain46.7% AI-predicted activityagainst K. pneumoniae50+ registered studies
- PalbociclibExisting use: Breast cancer, Breast carcinoma, Breast neoplasm and 3 more46.4% AI-predicted activityagainst K. pneumoniae50+ registered studies
- AnidulafunginExisting use: Candidemia, Candidiasis, Peritonitis46.1% AI-predicted activityagainst K. pneumoniae43 registered studies
- TemsirolimusExisting use: Cancer, Clear cell renal carcinoma, Mantle cell lymphoma and 2 more46.1% AI-predicted activityagainst K. pneumoniae50+ registered studies
Registered studies
A registration describes a study; it does not establish a positive result.
Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
NCT02819284 · start 2016-06
Registered record
- Registry ID
- NCT02819284
- Conditions
- Dry Eye Syndromes; Keratoconjunctivitis Sicca
- Interventions
- KPI-121 0.25% Ophthalmic Suspension; Vehicle of KPI-121 0.25% Ophthalmic Suspension
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Completed
- Start
- 2016-06
- Completion
- 2017-09
- Enrolment
- 909
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionDry Eye Syndromes; Keratoconjunctivitis SiccaInterventionKPI-121 0.25% Ophthalmic Suspension; Vehicle of KPI-121 0.25% Ophthalmic SuspensionPhasePhase 3Registry statusCompletedTopical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
NCT04075227 · start 2015-10-16
Registered record
- Registry ID
- NCT04075227
- Conditions
- Recurrent Pterygium of Eye; Steroid-Induced Glaucoma
- Interventions
- 0.2% loteprednol etabonate; 0.1% dexamethasone
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2015-10-16
- Completion
- 2019-03-02
- Enrolment
- 108
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionRecurrent Pterygium of Eye; Steroid-Induced GlaucomaIntervention0.2% loteprednol etabonate; 0.1% dexamethasonePhasePhase 4Registry statusCompletedEvaluation of the Safety, Systemic Pharmacokinetics, and Tolerability
NCT03063489 · start 2015-02
Registered record
- Registry ID
- NCT03063489
- Conditions
- Eye Pain
- Interventions
- Loteprednol Etabonate Ophthalmic Gel
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2015-02
- Completion
- 2015-07
- Enrolment
- 15
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionEye PainInterventionLoteprednol Etabonate Ophthalmic GelPhasePhase 1Registry statusCompletedLoteprednol vs. Prednisolone and Fluorometholone
NCT03123614 · start 2014-09-19
Registered record
- Registry ID
- NCT03123614
- Conditions
- Intraocular Pressure; Corneal Opacity
- Interventions
- Loteprednol Etabonate 0.5% Oph Gel; Prednisolone Acetate 1% Oph Susp
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2014-09-19
- Completion
- 2018-07
- Enrolment
- 131
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionIntraocular Pressure; Corneal OpacityInterventionLoteprednol Etabonate 0.5% Oph Gel; Prednisolone Acetate 1% Oph SuspPhasePhase 4Registry statusCompletedLoteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
NCT02208297 · start 2014-09
Registered record
- Registry ID
- NCT02208297
- Conditions
- Inflammation; Pain; Cataract
- Interventions
- Loteprednol Etabonate Gel (BID); Vehicle Gel (BID)
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Completed
- Start
- 2014-09
- Completion
- 2015-03
- Enrolment
- 326
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionInflammation; Pain; CataractInterventionLoteprednol Etabonate Gel (BID); Vehicle Gel (BID)PhasePhase 3Registry statusCompletedTopical Steroid Treatment For Dry Eye
NCT02218827 · start 2014-09
Registered record
- Registry ID
- NCT02218827
- Conditions
- Dry Eye
- Interventions
- Loteprednol Etabonate (FML)
- Study type
- INTERVENTIONAL
- Phase
- Not applicable
- Registry status
- Unknown
- Start
- 2014-09
- Completion
- 2015-09
- Enrolment
- 30
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionDry EyeInterventionLoteprednol Etabonate (FML)PhaseNot applicableRegistry statusUnknownSafety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
NCT02218489 · start 2014-07
Registered record
- Registry ID
- NCT02218489
- Conditions
- Blepharitis
- Interventions
- KPI-121; Vehicle
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Registry status
- Completed
- Start
- 2014-07
- Completion
- 2016-06
- Enrolment
- 206
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionBlepharitisInterventionKPI-121; VehiclePhasePhase 2Registry statusCompletedSafety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
NCT02188160 · start 2014-06
Registered record
- Registry ID
- NCT02188160
- Conditions
- Dry Eye Syndromes; Keratoconjunctivitis Sicca
- Interventions
- KPI-121; Placebo
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Registry status
- Completed
- Start
- 2014-06
- Completion
- 2015-03
- Enrolment
- 150
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionDry Eye Syndromes; Keratoconjunctivitis SiccaInterventionKPI-121; PlaceboPhasePhase 2Registry statusCompletedSafety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
NCT02163824 · start 2014-05
Registered record
- Registry ID
- NCT02163824
- Conditions
- Ocular Infections, Irritations and Inflammations
- Interventions
- KPI-121 0.25%; KPI-121 1.0%; Vehicle of KPI-121 0.25%; Vehicle of KPI-121 1.0%
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Completed
- Start
- 2014-05
- Completion
- 2014-12
- Enrolment
- 380
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionOcular Infections, Irritations and InflammationsInterventionKPI-121 0.25%; KPI-121 1.0%; Vehicle of KPI-121 0.25%; Vehicle of KPI-121 1.0%PhasePhase 3Registry statusCompletedA Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®
NCT02028312 · start 2014-01
Registered record
- Registry ID
- NCT02028312
- Conditions
- Dry Eye Disease
- Interventions
- Loteprednol etabonate; Artificial Tears; Restasis
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Withdrawn
- Start
- 2014-01
- Completion
- 2016-06
- Enrolment
- 0
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionDry Eye DiseaseInterventionLoteprednol etabonate; Artificial Tears; RestasisPhasePhase 4Registry statusWithdrawnLoteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
NCT01996839 · start 2013-12
Registered record
- Registry ID
- NCT01996839
- Conditions
- Inflammation; Pain; Cataract
- Interventions
- Loteprednol Etabonate Gel (BID); Loteprednol Etabonate Gel (TID); Vehicle (BID); Vehicle (TID)
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Completed
- Start
- 2013-12
- Completion
- 2014-07
- Enrolment
- 514
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionInflammation; Pain; CataractInterventionLoteprednol Etabonate Gel (BID); Loteprednol Etabonate Gel (TID); Vehicle (BID); Vehicle (TID)PhasePhase 3Registry statusCompletedLoteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
NCT01475643 · start 2013-06
Registered record
- Registry ID
- NCT01475643
- Conditions
- Cataract
- Interventions
- Loteprednol etabonate; Prednisolones acetate
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Completed
- Start
- 2013-06
- Completion
- 2017-07
- Enrolment
- 107
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionCataractInterventionLoteprednol etabonate; Prednisolones acetatePhasePhase 3Registry statusCompletedLotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
NCT01817582 · start 2013-05-17
Registered record
- Registry ID
- NCT01817582
- Conditions
- Keratoconjunctivitis Sicca
- Interventions
- Lotemax; Restasis; Soothe® Lubricant Eye Drops
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Registry status
- Completed
- Start
- 2013-05-17
- Completion
- 2014-01-10
- Enrolment
- 102
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionKeratoconjunctivitis SiccaInterventionLotemax; Restasis; Soothe® Lubricant Eye DropsPhasePhase 2Registry statusCompletedComparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
NCT01853696 · start 2013-03
Registered record
- Registry ID
- NCT01853696
- Conditions
- Fuchs' Dystrophy; Corneal Edema
- Interventions
- loteprednol etabonate; prednisolone acetate 1%
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2013-03
- Completion
- 2015-01
- Enrolment
- 167
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionFuchs' Dystrophy; Corneal EdemaInterventionloteprednol etabonate; prednisolone acetate 1%PhasePhase 4Registry statusCompletedTear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
NCT01736527 · start 2013-01
Registered record
- Registry ID
- NCT01736527
- Conditions
- Pharmacokinetics
- Interventions
- LE Gel
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2013-01
- Completion
- 2013-04
- Enrolment
- 12
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionPharmacokineticsInterventionLE GelPhasePhase 1Registry statusCompleted