Loteprednol

Generic Name: Loteprednol

Brand Names: Alrex, Lotemax, Zylet

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₇ClO_₅

CAS Number: 129260-79-3

Unique Ingredient Identifier: Z8CBU6KR16

Indication: 用于眼科局部炎症。0.2％浓度适用于暂时缓解季节性过敏性结膜炎；0.5％混悬液适用于治疗对类固醇有效的炎症，如结膜炎、角膜、前房炎、过敏性结膜炎、痤疮、酒糟鼻、表浅性点状角膜炎、疱疹、带状疱疹角膜炎、虹膜炎、睫状体炎等可适当减轻水肿和炎症。尚可用于眼科手术后炎症的治疗。

Associated Conditions: Chickenpox, Conjunctivitis infective, Cyclitis, Eye infection viral, Herpes Zoster Keratitis, Inflammation, Iritis, Ocular Inflammation, Rosacea, Seasonal Allergic Conjunctivitis, Superficial punctate keratitis

Clinical Trials

The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Not Applicable

Recruiting

Conditions: Age-Related Macular Degeneration

Interventions: Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]
Other: Refresh Lubricant Eye Drops [Artificial Tears]

First Posted Date: 2022-09-15

Last Posted Date: 2025-01-13

Lead Sponsor: Virginia Polytechnic Institute and State University

Target Recruit Count: 72

Registration Number: NCT05542381

Locations: 🇺🇸
Vistar Eye Center, Roanoke, Virginia, United States

Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial

Phase 1

Completed

Conditions: Vernal Keratoconjunctivitis
Cyclosporine 0.05% Eye Drops

Interventions: Drug: Cyclosporine 0.05% eye drops
Drug: Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%

First Posted Date: 2022-04-29

Last Posted Date: 2022-04-29

Lead Sponsor: Second Affiliated Hospital of Nanchang University

Target Recruit Count: 48

Registration Number: NCT05353101

Locations: 🇨🇳
the Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

Phase 4

Completed

Conditions: Corneal Endothelial Dystrophy
Corneal Edema

Interventions: Drug: loteprednol etabonate 0.25% ophthalmic suspension

First Posted Date: 2021-11-29

Last Posted Date: 2024-08-14

Lead Sponsor: Price Vision Group

Target Recruit Count: 70

Registration Number: NCT05136443

Locations: 🇺🇸
Price Vision Group, Indianapolis, Indiana, United States

DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Phase 4

Completed

Conditions: Bilateral Conjunctivitis (Disorder)

Interventions: Drug: Dexamethasone ophthalmic insert 0.4Mg
Drug: 0.2% loteprednol etabonate ophthalmic suspension
Drug: olopatadine hydrochloride ophthalmic solution 0.7%

First Posted Date: 2021-01-14

Last Posted Date: 2022-04-13

Lead Sponsor: Clinical Research Center of Florida

Target Recruit Count: 31

Registration Number: NCT04708821

Locations: 🇺🇸
Clinical Research Center of Florida, Pompano Beach, Florida, United States

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus

Early Phase 1

Completed

Conditions: Keratoconus
Allergy
Dry Eye

Interventions: Drug: dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use
Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly

First Posted Date: 2020-06-05

Last Posted Date: 2025-04-06

Lead Sponsor: Illinois College of Optometry

Target Recruit Count: 36

Registration Number: NCT04418999

Locations: 🇺🇸
Illinois Eye Institute, Chicago, Illinois, United States

Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

Phase 4

Completed

Conditions: Recurrent Pterygium of Eye
Steroid-Induced Glaucoma

Interventions: Drug: 0.2% loteprednol etabonate
Drug: 0.1% dexamethasone

First Posted Date: 2019-08-30

Last Posted Date: 2019-09-06

Lead Sponsor: Wannisa Suphachearabhan

Target Recruit Count: 108

Registration Number: NCT04075227

Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

Phase 1

Completed

Conditions: Inflammation Following Ocular Surgery

Interventions: Drug: Generic Loteprednol Etabonate
Drug: Reference Listed Drug (RLD)

First Posted Date: 2018-05-22

Last Posted Date: 2019-11-06

Lead Sponsor: Sandoz

Target Recruit Count: 381

Registration Number: NCT03531697

Locations: 🇨🇦
Sandoz Investigative Site, Multiple Locations, Canada

Loteprednol vs. Prednisolone and Fluorometholone

Phase 4

Completed

Conditions: Intraocular Pressure
Corneal Opacity

Interventions: Drug: Loteprednol Etabonate 0.5% Oph Gel
Drug: Prednisolone Acetate 1% Oph Susp

First Posted Date: 2017-04-21

Last Posted Date: 2021-05-26

Lead Sponsor: University of Utah

Target Recruit Count: 131

Registration Number: NCT03123614

Locations: 🇺🇸
Moran Eye Center - Midvalley Location, Murray, Utah, United States

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Phase 1

Completed

Conditions: Eye Pain

Interventions: Drug: Loteprednol Etabonate Ophthalmic Gel

First Posted Date: 2017-02-24

Last Posted Date: 2017-02-24

Lead Sponsor: Bausch Health Americas, Inc.

Target Recruit Count: 15

Registration Number: NCT03063489

Locations: 🇺🇸
Valeant Site 03, Oceanside, California, United States
🇺🇸
Valeant Site 05, Miami, Florida, United States
🇺🇸
Valeant Site 06, Kansas City, Missouri, United States

and more 3 locations

Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study

Phase 4

Conditions: Must be PRK Candidate

Interventions: Drug: Loteprednol (Lotemax)
Drug: Fluorometholone(FML)

First Posted Date: 2016-11-28

Last Posted Date: 2016-11-28

Lead Sponsor: Dr Salouti Eye Research Center

Target Recruit Count: 200

Registration Number: NCT02974387

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