Clinical Trials

Numerous clinical trials evaluate loteprednol etabonate across early phase 1 through phase 4 to treat various ophthalmic conditions, including eye pain, dry eye disease, post-surgical ocular inflammation, allergic conjunctivitis, and macular edema. Sponsored by pharmaceutical entities alongside academic and clinical institutions, these studies assess both therapeutic efficacy and ocular safety. While a significant proportion of these registered trials have reached completed status, others are marked as withdrawn or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07496060 COMPLETED
Anterior Chamber Granulomatous Uveitis
Fayoum University
 2025-08-10 PHASE4
NCT05542381 COMPLETED
Age-Related Macular Degeneration
Virginia Polytechnic Institute and State University
 2022-12-22
NCT05136443 COMPLETED
Corneal Endothelial Dystrophy; Corneal Edema
Price Vision Group
 2021-11-23 PHASE4
NCT07090044 COMPLETED
Vein Occlusion; Macular Degeneration Choroidal Neovascularization; Macular Edema; Diabetic Retinopathy
Retina Research Institute, LLC
 2021-08-20 PHASE4
NCT05322148 COMPLETED
Dry Eye
Research Insight LLC
 2022-06-03 PHASE3
NCT04555694 COMPLETED
Dry Eye
Thomas Chester, OD
 2020-10-01 PHASE4
NCT04418999 COMPLETED
Keratoconus; Dry Eye; Allergy
Illinois College of Optometry
 2020-09-01 EARLY_PHASE1
NCT04708821 COMPLETED
Bilateral Conjunctivitis (Disorder)
Clinical Research Center of Florida
 2021-04-30 PHASE4
NCT07588074 COMPLETED
Ocular Inflammation; Keratoconjunctivitis; Dry Eye Disease (DED); Post-operative Complications; Kerato Conjunctivitis Sicca; Dry Eye Syndromes; Postoperative Complications
Harrow Inc
 2021-05-01 PHASE4
NCT05353101 COMPLETED
Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops
Second Affiliated Hospital of Nanchang University
 2020-07-01 PHASE1
NCT03531697 COMPLETED
Inflammation Following Ocular Surgery
Sandoz
 2018-04-26 PHASE1
NCT04075227 COMPLETED
Recurrent Pterygium of Eye; Steroid-Induced Glaucoma
Wannisa Suphachearabhan
 2015-10-16 PHASE4
NCT03123614 COMPLETED
Intraocular Pressure; Corneal Opacity
University of Utah
 2014-09-19 PHASE4
NCT02786901 COMPLETED
Cataract; Pain; Ocular Inflammation
Bausch & Lomb Incorporated
 2016-06 PHASE3
NCT01475643 COMPLETED
Cataract
Bausch & Lomb Incorporated
 2013-06 PHASE3
NCT03098953 COMPLETED
Healthy
Bausch & Lomb Incorporated
 2017-04-10 PHASE1
NCT02028312 WITHDRAWN
Dry Eye Disease
Edward Holland, MD
 2014-01 PHASE4
NCT01437982 COMPLETED
Conjunctivitis, Seasonal Allergic; Conjunctivitis, Giant Papillary; Inflammation
Bausch & Lomb Incorporated
 2010-08-05 PHASE4
NCT02218827 UNKNOWN
Dry Eye
Meir Medical Center
 2014-09
NCT03063489 COMPLETED
Eye Pain
Bausch Health Americas, Inc.
 2015-02 PHASE1
NCT01749241 WITHDRAWN
Post-operative Healing Following Blepharoplasty and Ptosis Repair
University of California, San Diego
 2012-09
NCT02208297 COMPLETED
Inflammation; Pain; Cataract
Bausch & Lomb Incorporated
 2014-09 PHASE3
NCT03063489 Completed
Eye Pain
Bausch Health Americas Inc.
 2015-02 Phase 1
NCT01853696 COMPLETED
Fuchs' Dystrophy; Corneal Edema
Cornea Research Foundation of America
 2013-03 PHASE4
NCT01996839 COMPLETED
Inflammation; Pain; Cataract
Bausch & Lomb Incorporated
 2013-12 PHASE3
NCT01724892 COMPLETED
Epithelial Defect After Phototherapeutic Keratectomy
Khon Kaen University
 2012-11 PHASE4
NCT01692652 COMPLETED
Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)
Yonsei University
 2012-08
NCT01736527 COMPLETED
Pharmacokinetics
Bausch & Lomb Incorporated
 2013-01 PHASE1
NCT01443442 COMPLETED
Allergic Conjunctivitis
Southern California College of Optometry at Marshall B. Ketchum University
 2011-10 PHASE4
NCT01435460 COMPLETED
Seasonal Allergic Conjunctivitis
Bausch & Lomb Incorporated
 2010-08 PHASE3
NCT01060072 COMPLETED
Inflammation; Pain
Bausch & Lomb Incorporated
 2010-02 PHASE3
NCT01010633 COMPLETED
Inflammation; Pain
Bausch & Lomb Incorporated
 2009-11 PHASE3
NCT01107405 COMPLETED
Allergic Conjunctivitis
Bausch & Lomb Incorporated
 2010-04 PHASE2
NCT00705159 COMPLETED
Conjunctivitis
Bausch & Lomb Incorporated
 2008-06 PHASE4
NCT00699153 COMPLETED
Ocular Inflammation
Bausch & Lomb Incorporated
 2008-06 PHASE3
NCT00645671 COMPLETED
Ocular Inflammation
Bausch & Lomb Incorporated
 2008-03 PHASE3
NCT00420628 COMPLETED
Chalazion; Hordeolum
Bausch & Lomb Incorporated
 2006-11 PHASE4
NCT00689078 COMPLETED
Allergic Conjunctivitis
ORA, Inc.
 2008-05 PHASE4
NCT00447577 COMPLETED
Blepharokeratoconjunctivitis
Bausch & Lomb Incorporated
 2007-01 PHASE4
NCT00781300 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Federal University of São Paulo
 2006-03 PHASE4
NCT00560638 COMPLETED
Dry Eye
Bausch & Lomb Incorporated
 2005-11 PHASE2
NCT00532961 COMPLETED
Inflammation
Bausch & Lomb Incorporated
 2005-02 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-03-27)

Check the Loteprednol etabonate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Loteprednol etabonate selectively binds to and activates the glucocorticoid receptor, thereby inhibiting pro-inflammatory cytokine synthesis and suppressing phospholipase A2 activity to reduce arachidonic acid derivative formation. This inhibition of downstream inflammatory mediators suppresses leukocyte recruitment and vascular permeability, mitigating ocular inflammation and pain associated with dry eye disease, allergic conjunctivitis, and post-surgical recovery.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.