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ClinicalTrials.gov public records Last synced Oct 2, 2026, 9:15 AM EDT

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Showing 25–48 of 48 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Loteprednol Etabonate Clear all
Completed Phase 3 Interventional Results available

Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

NCT01010633
View directory record Official record
Conditions
Inflammation, Pain
Interventions
Vehicle of Loteprednol Etabonate, Loteprednol Etabonate
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
406 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Jan 9, 2012 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional

Tolerability Comparison of Flarex to Lotemax SM

NCT07588074
View directory record Official record
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%
Drug
Lead sponsor
Harrow Inc
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
Baton Rouge, Louisiana
Source: ClinicalTrials.gov public record
Updated Sep 22, 2026 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional Results available

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

NCT05136443
View directory record Official record
Conditions
Corneal Endothelial Dystrophy, Corneal Edema
Interventions
loteprednol etabonate 0.25% ophthalmic suspension
Drug
Lead sponsor
Price Vision Group
Industry
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Aug 14, 2024 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

NCT00645671
View directory record Official record
Conditions
Ocular Inflammation
Interventions
0.5% Loteprednol Etabonate Ophthalmic Ointment, Vehicle of Loteprednol Etabonate Ophthalmic Ointment
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Mar 24, 2015 · Synced Oct 2, 2026, 9:15 AM EDT
Completed No phase listed Observational Results available

A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin

NCT00834171
View directory record Official record
Conditions
Ocular Hypertension
Interventions
Loteprednol etabonate ophthalmic suspension 0.5%, Loteprednol etabonate (0.5%) and tobramycin (0.3%).
Drug
Lead sponsor
Allergan
Industry
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009
U.S. locations
1
States / cities
Maclean, Virginia
Source: ClinicalTrials.gov public record
Updated Sep 26, 2011 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional Results available

Loteprednol vs. Prednisolone and Fluorometholone

NCT03123614
View directory record Official record
Conditions
Intraocular Pressure, Corneal Opacity
Interventions
Loteprednol Etabonate 0.5% Oph Gel, Prednisolone Acetate 1% Oph Susp
Drug
Lead sponsor
University of Utah
Other
Eligibility
21 Years and older
Enrollment
131 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
Murray, Utah
Source: ClinicalTrials.gov public record
Updated May 26, 2021 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis

NCT00407043
View directory record Official record
Conditions
Dry Eye Disease, Keratoconjunctivitis Sicca
Interventions
Lotemax, Restasis
Drug
Lead sponsor
Ophthalmic Consultants of Long Island
Other
Eligibility
30 Years to 80 Years
Enrollment
5 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2007
U.S. locations
1
States / cities
Lynbrook, New York
Source: ClinicalTrials.gov public record
Updated Jul 21, 2011 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation

NCT02163824
View directory record Official record
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%
Drug
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
23
States / cities
Artesia, California • Mission Hills, California • Rancho Cordova, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jan 29, 2021 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

NCT00699153
View directory record Official record
Conditions
Ocular Inflammation
Interventions
Loteprednol Etabonate, Vehicle of Ophthalmic Loteprednol Etabonate
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 24, 2015 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional

Zylet vs TobraDex in Blepharokeratoconjunctivitis

NCT00447577
View directory record Official record
Conditions
Blepharokeratoconjunctivitis
Interventions
Loteprednol etabonate and tobramycin ophthalmic suspension, Tobramycin and dexamethasone ophthalmic suspension
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
276 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 9, 2011 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

NCT01060072
View directory record Official record
Conditions
Inflammation, Pain
Interventions
Loteprednol etabonate, Vehicle of Loteprednol Etabonate
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
407 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Jan 13, 2012 · Synced Oct 2, 2026, 9:15 AM EDT
Not listed Phase 4 Interventional Accepts healthy volunteers

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
View directory record Official record
Conditions
Pseudophakia, Cataract Surgery
Interventions
Pred Forte, Lotemax
Drug
Lead sponsor
Innovative Medical
Industry
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2012
U.S. locations
3
States / cities
Laguna Hills, California • Miami, Florida • Waltham, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 14, 2012 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

NCT02813265
View directory record Official record
Conditions
Dry Eye Syndromes, Keratoconjunctivitis Sicca
Interventions
KPI-121 0.25% Ophthalmic Suspension, Vehicle of KPI-121 0.25% Ophthalmic Suspension
Drug
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
918 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
60
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Little Rock, Arkansas + 53 more
Source: ClinicalTrials.gov public record
Updated Feb 3, 2021 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional

Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period

NCT07090044
View directory record Official record
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
Drug
Lead sponsor
Retina Research Institute, LLC
Other
Eligibility
18 Years and older
Enrollment
77 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jul 29, 2025 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional Results available

Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

NCT01853696
View directory record Official record
Conditions
Fuchs' Dystrophy, Corneal Edema
Interventions
loteprednol etabonate, prednisolone acetate 1%
Drug
Lead sponsor
Cornea Research Foundation of America
Other
Eligibility
18 Years and older
Enrollment
167 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated May 15, 2015 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease

NCT02218489
View directory record Official record
Conditions
Blepharitis
Interventions
KPI-121, Vehicle
Drug
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
206 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
8
States / cities
Birmingham, Alabama • Artesia, California • Mission Hills, California + 5 more
Source: ClinicalTrials.gov public record
Updated Jan 11, 2021 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

NCT01996839
View directory record Official record
Conditions
Inflammation, Pain, Cataract
Interventions
Loteprednol Etabonate Gel (BID), Loteprednol Etabonate Gel (TID), Vehicle (BID), Vehicle (TID)
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
514 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 25, 2020 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional Results available

Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

NCT01443442
View directory record Official record
Conditions
Allergic Conjunctivitis
Interventions
bepotastine besilate, 1.5%, Loteprednol etabonate
Drug
Lead sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
2
States / cities
Fullerton, California
Source: ClinicalTrials.gov public record
Updated Aug 6, 2019 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

NCT02786901
View directory record Official record
Conditions
Cataract, Pain, Ocular Inflammation
Interventions
Loteprednol Etabonate Ophthalmic Gel dosed TID, Loteprednol Etabonate Ophthalmic Gel dosed BID, Vehicle Gel
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
6
States / cities
Phoenix, Arizona • Oceanside, California • Miami, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Jan 8, 2021 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Not applicable Interventional

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

NCT05542381
View directory record Official record
Conditions
Age-Related Macular Degeneration
Interventions
Loteprednol Etabonate Ophthalmic Gel [Lotemax], Refresh Lubricant Eye Drops [Artificial Tears]
Drug · Other
Lead sponsor
Virginia Polytechnic Institute and State University
Other
Eligibility
18 Years and older
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Roanoke, Virginia
Source: ClinicalTrials.gov public record
Updated Sep 19, 2025 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease

NCT02819284
View directory record Official record
Conditions
Dry Eye Syndromes, Keratoconjunctivitis Sicca
Interventions
KPI-121 0.25% Ophthalmic Suspension, Vehicle of KPI-121 0.25% Ophthalmic Suspension
Drug
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
909 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
62
States / cities
Birmingham, Alabama • Chandler, Arizona • Jonesboro, Arkansas + 54 more
Source: ClinicalTrials.gov public record
Updated Jan 5, 2021 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 4 Interventional

DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

NCT04708821
View directory record Official record
Conditions
Bilateral Conjunctivitis (Disorder)
Interventions
Dexamethasone ophthalmic insert 0.4Mg, 0.2% loteprednol etabonate ophthalmic suspension, olopatadine hydrochloride ophthalmic solution 0.7%
Drug
Lead sponsor
Clinical Research Center of Florida
Other
Eligibility
18 Years and older
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
Pompano Beach, Florida
Source: ClinicalTrials.gov public record
Updated Apr 13, 2022 · Synced Oct 2, 2026, 9:15 AM EDT
Completed No phase listed Observational Results available

Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery

NCT01344226
View directory record Official record
Conditions
Pseudophakia, Inflammation
Interventions
loteprednol 0.5% ophthalmic solution
Drug
Lead sponsor
Toyos Clinic
Other
Eligibility
18 Years and older
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
Independence, Missouri
Source: ClinicalTrials.gov public record
Updated Oct 22, 2018 · Synced Oct 2, 2026, 9:15 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

NCT03098953
View directory record Official record
Conditions
Healthy
Interventions
Loteprednol Etabonate
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Inglewood, California
Source: ClinicalTrials.gov public record
Updated May 18, 2017 · Synced Oct 2, 2026, 9:15 AM EDT