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Showing 1–24 of 48 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: loteprednol etabonate Clear all
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 28, 2021 · Synced Sep 24, 2026, 4:41 PM EDT
Completed Phase 3 Interventional Results available

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

NCT02793817
View directory record Official record
Conditions
Post Surgical Ocular Inflammation and Pain
Interventions
KPI-121 1% Ophthalmic Suspension dosed BID, Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Drug
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
520 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
35
States / cities
Chandler, Arizona • Phoenix, Arizona • Artesia, California + 32 more
Source: ClinicalTrials.gov public record
Updated Dec 15, 2020 · Synced Sep 24, 2026, 4:41 PM 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 21, 2026 · Synced Sep 24, 2026, 4:41 PM EDT
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 8, 2012 · Synced Sep 24, 2026, 4:41 PM 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 20, 2011 · Synced Sep 24, 2026, 4:41 PM 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 17, 2017 · Synced Sep 24, 2026, 4:41 PM EDT
Completed Phase 2 Interventional

Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

NCT00560638
View directory record Official record
Conditions
Dry Eye
Interventions
loteprednol etabonate ophthalmic suspension, 0.5%, vehicle of loteprednol etabonate
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
119 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
1
States / cities
Andover, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 17, 2011 · Synced Sep 24, 2026, 4:41 PM EDT
Completed Phase 3 Interventional Results available

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

NCT02208297
View directory record Official record
Conditions
Inflammation, Pain, Cataract
Interventions
Loteprednol Etabonate Gel (BID), Vehicle Gel (BID)
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
326 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 24, 2020 · Synced Sep 24, 2026, 4:41 PM EDT
Not listed Phase 4 Interventional Accepts healthy volunteers

Use of Loteprednol for Contact Lens Intolerance and Dryness

NCT00817557
View directory record Official record
Conditions
Contact Lenses Dryness
Interventions
Loteprednol, Rewetter
Drug · Other
Lead sponsor
Hom, Milton M., OD, FAAO
Individual
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Azusa, California
Source: ClinicalTrials.gov public record
Updated Jan 5, 2009 · Synced Sep 24, 2026, 4:41 PM 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 23, 2015 · Synced Sep 24, 2026, 4:41 PM 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 14, 2015 · Synced Sep 24, 2026, 4:41 PM EDT
Completed Phase 4 Interventional Results available

The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

NCT02120079
View directory record Official record
Conditions
Dry Eye Disease
Interventions
Lotemax, Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears), In Vivo Confocal Microscopy (IVCM)
Drug · Diagnostic Test
Lead sponsor
Tufts Medical Center
Other
Eligibility
18 Years to 89 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 25, 2024 · Synced Sep 24, 2026, 4:41 PM EDT
Completed Phase 3 Interventional Accepts healthy volunteers

Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization

NCT05322148
View directory record Official record
Conditions
Dry Eye
Interventions
Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free
Drug
Lead sponsor
Research Insight LLC
Industry
Eligibility
18 Years and older
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
3
States / cities
Hemet, California • Laguna Hills, California • Brecksville, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 3, 2023 · Synced Sep 24, 2026, 4:41 PM 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 8, 2011 · Synced Sep 24, 2026, 4:41 PM 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 18, 2025 · Synced Sep 24, 2026, 4:41 PM 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 13, 2012 · Synced Sep 24, 2026, 4:41 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

NCT04555694
View directory record Official record
Conditions
Dry Eye
Interventions
Cyclosporine, Loteprednol Etabonate, Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Drug
Lead sponsor
Thomas Chester, OD
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2022
U.S. locations
1
States / cities
Brecksville, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 10, 2023 · Synced Sep 24, 2026, 4:41 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

NCT01736527
View directory record Official record
Conditions
Pharmacokinetics
Interventions
LE Gel
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Nov 7, 2013 · Synced Sep 24, 2026, 4:41 PM 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 25, 2011 · Synced Sep 24, 2026, 4:41 PM EDT
Withdrawn Not applicable Interventional Accepts healthy volunteers

Efficacy of Loteprednol Ointment Following Eyelid Surgery

NCT01749241
View directory record Official record
Conditions
Post-operative Healing Following Blepharoplasty and Ptosis Repair
Interventions
Loteprednol etabonate ophthalmic ointment, Vehicle Ophthalmic Ointment
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years and older
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2015
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Aug 1, 2019 · Synced Sep 24, 2026, 4:41 PM 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 21, 2018 · Synced Sep 24, 2026, 4:41 PM 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 4, 2021 · Synced Sep 24, 2026, 4:41 PM 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 13, 2024 · Synced Sep 24, 2026, 4:41 PM 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 12, 2022 · Synced Sep 24, 2026, 4:41 PM EDT