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.
- AfamelanotideExisting use: Erythropoietic protoporphyria65.1% AI-predicted activityagainst MRSA23 registered studies
- TriclosanExisting use: Phenol and derivatives, Medicated dressings with antiinfectives64.9% AI-predicted activityagainst MRSALab records exist50+ registered studies
- Imatinib MesylateExisting use: Acute lymphoblastic leukemia, B-cell acute lymphoblastic leukemia, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 7 more64.9% AI-predicted activityagainst MRSA50+ registered studies
- Naldemedine TosylateExisting use: Constipation, Constipation disorder64.8% AI-predicted activityagainst MRSA1 registered study
- Vorapaxar SulfateExisting use: Myocardial infarction, Peripheral arterial disease, Recurrent thrombophlebitis and 1 more64.8% AI-predicted activityagainst MRSA15 registered studies
- Rimegepant SulfateExisting use: Migraine disorder64.7% AI-predicted activityagainst MRSA50+ registered studies
- Terlipressin AcetateExisting use: Hepatorenal syndrome, Kidney failure, Renal insufficiency64.6% AI-predicted activityagainst MRSA7 registered studies
- Bremelanotide AcetateExisting use: Mental or behavioural disorder, Physiological sexual disorder, Sexual dysfunction64.5% AI-predicted activityagainst MRSA1 registered study
- Tazemetostat HydrobromideExisting use: Follicular lymphoma, Neoplasm, Sarcoma64.4% AI-predicted activityagainst MRSA3 registered studies
- Isavuconazonium SulfateExisting use: Aspergillosis, Mucormycosis64.3% AI-predicted activityagainst MRSA50+ registered studies
- Nirogacestat HydrobromideExisting use: Gastrointestinal desmoid tumor64.2% AI-predicted activityagainst MRSA1 registered study
- Prasugrel HydrochlorideExisting use: Acute coronary syndrome, Hemorrhage, Intermediate coronary syndrome and 1 more64.2% AI-predicted activityagainst MRSA50+ registered studies
Registered studies
A registration describes a study; it does not establish a positive result.
Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease
NCT07671222 · start 2026-12
Registered record
- Registry ID
- NCT07671222
- Conditions
- Sjogren Syndrome; Sjogren Syndrome With Keratoconjunctivitis; Dry Eye Disease (DED)
- Interventions
- Infliximab 0.1%; Loteprednol
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Registry status
- Not yet recruiting
- Start
- 2026-12
- Completion
- 2028-03
- Enrolment
- 38
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionSjogren Syndrome; Sjogren Syndrome With Keratoconjunctivitis; Dry Eye Disease (DED)InterventionInfliximab 0.1%; LoteprednolPhasePhase 2Registry statusNot yet recruitingAutologous Plasma Rich in Growth Factors for Severe Dry Eye Disease
NCT07773740 · start 2026-08-25
Registered record
- Registry ID
- NCT07773740
- Conditions
- Dry Eye Disease With Severe Keratitis
- Interventions
- PRGF; Balanced Salt Solution (BSS®)
- Study type
- INTERVENTIONAL
- Phase
- Not applicable
- Registry status
- Not yet recruiting
- Start
- 2026-08-25
- Completion
- 2027-08
- Enrolment
- 100
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionDry Eye Disease With Severe KeratitisInterventionPRGF; Balanced Salt Solution (BSS®)PhaseNot applicableRegistry statusNot yet recruitingLoteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas
NCT07496060 · start 2025-08-10
Registered record
- Registry ID
- NCT07496060
- Conditions
- Anterior Chamber Granulomatous Uveitis
- Interventions
- loteprednol etabonate 1% arm 1; prednisolone acete 1%
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2025-08-10
- Completion
- 2026-01-13
- Enrolment
- 66
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAnterior Chamber Granulomatous UveitisInterventionloteprednol etabonate 1% arm 1; prednisolone acete 1%PhasePhase 4Registry statusCompletedThe Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
NCT05542381 · start 2022-12-22
Registered record
- Registry ID
- NCT05542381
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Loteprednol Etabonate Ophthalmic Gel [Lotemax]; Refresh Lubricant Eye Drops [Artificial Tears]
- Study type
- INTERVENTIONAL
- Phase
- Not applicable
- Registry status
- Completed
- Start
- 2022-12-22
- Completion
- 2025-05-01
- Enrolment
- 64
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAge-Related Macular DegenerationInterventionLoteprednol Etabonate Ophthalmic Gel [Lotemax]; Refresh Lubricant Eye Drops [Artificial Tears]PhaseNot applicableRegistry statusCompletedComparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period
NCT07090044 · start 2021-08-20
Registered record
- Registry ID
- NCT07090044
- Conditions
- Vein Occlusion; Macular Degeneration Choroidal Neovascularization; Macular Edema; Diabetic Retinopathy
- Interventions
- Bromfenac Sodium 0.07%; Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly; Propylene Glycol Preservative-free Artificial Tears
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2021-08-20
- Completion
- 2022-12-08
- Enrolment
- 77
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionVein Occlusion; Macular Degeneration Choroidal Neovascularization; Macular Edema; Diabetic RetinopathyInterventionBromfenac Sodium 0.07%; Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly; Propylene Glycol Preservative-free Artificial TearsPhasePhase 4Registry statusCompletedThe DEPOT Study (Dry Eye Prescription Options for Therapy)
NCT04911361 · start 2021-08-10
Registered record
- Registry ID
- NCT04911361
- Conditions
- Dry Eye
- Interventions
- Dexamethasone
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2021-08-10
- Completion
- 2021-12-28
- Enrolment
- 50
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionDry EyeInterventionDexamethasonePhasePhase 4Registry statusCompletedTolerability Comparison of Flarex to Lotemax SM
NCT07588074 · start 2021-05-01
Registered record
- Registry ID
- NCT07588074
- Conditions
- Ocular Inflammation; Keratoconjunctivitis; Dry Eye Disease (DED); Post-operative Complications; Kerato Conjunctivitis Sicca; Dry Eye Syndromes; Postoperative Complications
- Interventions
- Fluorometholone Acetate Ophthalmic Suspension 0.1%; Loteprednol Etabonate Ophthalmic Gel 0.38%
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2021-05-01
- Completion
- 2021-06-30
- Enrolment
- 40
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionOcular Inflammation; Keratoconjunctivitis; Dry Eye Disease (DED); Post-operative Complications +3 moreInterventionFluorometholone Acetate Ophthalmic Suspension 0.1%; Loteprednol Etabonate Ophthalmic Gel 0.38%PhasePhase 4Registry statusCompletedComparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
NCT04555694 · start 2020-10-01
Registered record
- Registry ID
- NCT04555694
- Conditions
- Dry Eye
- Interventions
- Cyclosporine; Loteprednol Etabonate; Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Completed
- Start
- 2020-10-01
- Completion
- 2022-02-16
- Enrolment
- 30
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionDry EyeInterventionCyclosporine; Loteprednol Etabonate; Dexamethasone Ophthalmic 0.4 Mg Ophthalmic InsertPhasePhase 4Registry statusCompletedSafety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
NCT04418999 · start 2020-09-01
Registered record
- Registry ID
- NCT04418999
- Conditions
- Keratoconus; Dry Eye; Allergy
- Interventions
- dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use; Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
- Study type
- INTERVENTIONAL
- Phase
- Early phase 1
- Registry status
- Completed
- Start
- 2020-09-01
- Completion
- 2021-12-31
- Enrolment
- 36
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionKeratoconus; Dry Eye; AllergyInterventiondexamethasone ophthalmic insert 0.4 mg, for intracanalicular use; Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyPhaseEarly phase 1Registry statusCompletedCyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial
NCT05353101 · start 2020-07-01
Registered record
- Registry ID
- NCT05353101
- Conditions
- Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops
- Interventions
- Cyclosporine 0.05% eye drops; Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2020-07-01
- Completion
- 2021-06-01
- Enrolment
- 48
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionVernal Keratoconjunctivitis; Cyclosporine 0.05% Eye DropsInterventionCyclosporine 0.05% eye drops; Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%PhasePhase 1Registry statusCompletedStudy of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
NCT03531697 · start 2018-04-26
Registered record
- Registry ID
- NCT03531697
- Conditions
- Inflammation Following Ocular Surgery
- Interventions
- Generic Loteprednol Etabonate; Reference Listed Drug (RLD)
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2018-04-26
- Completion
- 2019-10-07
- Enrolment
- 381
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionInflammation Following Ocular SurgeryInterventionGeneric Loteprednol Etabonate; Reference Listed Drug (RLD)PhasePhase 1Registry statusCompletedEvaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations
NCT03098953 · start 2017-04-10
Registered record
- Registry ID
- NCT03098953
- Conditions
- Healthy
- Interventions
- Loteprednol Etabonate
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2017-04-10
- Completion
- 2017-05-12
- Enrolment
- 15
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionHealthyInterventionLoteprednol EtabonatePhasePhase 1Registry statusCompletedSafety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
NCT02974387 · start 2017-04
Registered record
- Registry ID
- NCT02974387
- Conditions
- Must be PRK Candidate
- Interventions
- Fluorometholone(FML); Loteprednol (Lotemax)
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Unknown
- Start
- 2017-04
- Completion
- 2017-11
- Enrolment
- 200
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionMust be PRK CandidateInterventionFluorometholone(FML); Loteprednol (Lotemax)PhasePhase 4Registry statusUnknownDexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery
NCT02825186 · start 2016-07
Registered record
- Registry ID
- NCT02825186
- Conditions
- Ophthalmology
- Interventions
- Loteprendol etabonate 0.5%; Dexamethasone 0.1%
- Study type
- INTERVENTIONAL
- Phase
- Not applicable
- Registry status
- Unknown
- Start
- 2016-07
- Completion
- 2018-06
- Enrolment
- 100
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionOphthalmologyInterventionLoteprendol etabonate 0.5%; Dexamethasone 0.1%PhaseNot applicableRegistry statusUnknownSafety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
NCT02793817 · start 2016-06
Registered record
- Registry ID
- NCT02793817
- Conditions
- Post Surgical Ocular Inflammation and Pain
- Interventions
- KPI-121 1% Ophthalmic Suspension dosed BID; Vehicle of KPI-121 Ophthalmic Suspension dosed BID
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Completed
- Start
- 2016-06
- Completion
- 2017-03
- Enrolment
- 520
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionPost Surgical Ocular Inflammation and PainInterventionKPI-121 1% Ophthalmic Suspension dosed BID; Vehicle of KPI-121 Ophthalmic Suspension dosed BIDPhasePhase 3Registry statusCompleted