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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Loteprednol Clear all
Completed Phase 2 Interventional Results available

Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

NCT01817582
View directory record Official record
Conditions
Keratoconjunctivitis Sicca
Interventions
Lotemax, Restasis, Soothe® Lubricant Eye Drops
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
40 Years and older
Enrollment
102 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Irvine, California
Source: ClinicalTrials.gov public record
Updated Aug 29, 2019 · Synced Sep 23, 2026, 10:31 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 23, 2026, 10:31 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 23, 2026, 10:31 PM 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 2, 2021 · Synced Sep 23, 2026, 10:31 PM 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 28, 2021 · Synced Sep 23, 2026, 10:31 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 23, 2026, 10:31 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 23, 2026, 10:31 PM EDT
Completed Not applicable Interventional Results available

Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

NCT02322528
View directory record Official record
Conditions
Sjogren's Disease
Interventions
Administration of Lotemax
Drug
Lead sponsor
University of Rochester
Other
Eligibility
50 Years to 70 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Oct 15, 2015 · Synced Sep 23, 2026, 10:31 PM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers Results available

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

NCT04418999
View directory record Official record
Conditions
Keratoconus, Dry Eye, Allergy
Interventions
dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use, Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
Drug
Lead sponsor
Illinois College of Optometry
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jun 23, 2026 · Synced Sep 23, 2026, 10:31 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 23, 2026, 10:31 PM 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 24, 2020 · Synced Sep 23, 2026, 10:31 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 23, 2026, 10:31 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 23, 2026, 10:31 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 23, 2026, 10:31 PM 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 10, 2021 · Synced Sep 23, 2026, 10:31 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 23, 2026, 10:31 PM EDT
Completed Phase 4 Interventional

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery

NCT04521140
View directory record Official record
Conditions
Corneal Edema, Corneal Defect, Corneal Transplant, Penetrating KeratoPlasty, Anterior Chamber Inflammation, Ocular Pain, Intraocular Pressure
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp
Drug
Lead sponsor
Nicole Fram M.D.
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jul 23, 2023 · Synced Sep 23, 2026, 10:31 PM EDT
Completed Phase 2 Interventional Results available

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

NCT01107405
View directory record Official record
Conditions
Allergic Conjunctivitis
Interventions
Loteprednol etabonate base (QD), Loteprednol etabonate base (BID), Loteprednol etabonate base (QID), Loteprednol etabonate suspension, Vehicle of loteprednol etabonate
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
10 Years and older
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Mar 20, 2012 · Synced Sep 23, 2026, 10:31 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 23, 2026, 10:31 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 23, 2026, 10:31 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery

NCT01384266
View directory record Official record
Conditions
Intraocular Inflammation
Interventions
Not listed
Lead sponsor
Associated Eye Care, Minnesota
Other
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2011
U.S. locations
2
States / cities
Edgewood, Kentucky • Stillwater, Minnesota
Source: ClinicalTrials.gov public record
Updated Jun 28, 2017 · Synced Sep 23, 2026, 10:31 PM EDT
Completed Not applicable Interventional Results available

Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema

NCT02245516
View directory record Official record
Conditions
Retinal Vein Occlusion, Diabetic Macular Edema
Interventions
KPI-121 0.25% Ophthalmic Suspension, KPI-121 1.0% Ophthalmic Suspension
Drug
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
2
States / cities
Beverly Hills, California • Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Dec 9, 2020 · Synced Sep 23, 2026, 10:31 PM EDT
Completed Phase 4 Interventional Results available

Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis

NCT01456780
View directory record Official record
Conditions
Meibomian Gland Dysfunction, Posterior Blepharitis
Interventions
Loteprednol/tobramycin, Loteprednol, B+L Advanced Eye Relief Lubricant Drop
Drug
Lead sponsor
Massachusetts Eye and Ear Infirmary
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 31, 2017 · Synced Sep 23, 2026, 10:31 PM 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 7, 2021 · Synced Sep 23, 2026, 10:31 PM EDT