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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Lotemax Clear all
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 1, 2026, 2:02 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 1, 2026, 2:02 PM EDT
Completed Phase 4 Interventional Results available

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

NCT00689078
View directory record Official record
Conditions
Allergic Conjunctivitis
Interventions
Prednisolone Acetate 1%, Prednisolone Acetate 0.12%, Loteprednol Etabonate 0.2%, Placebo
Drug
Lead sponsor
ORA, Inc.
Industry
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Andover, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 1, 2020 · Synced Sep 1, 2026, 2:02 PM 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 12, 2012 · Synced Sep 1, 2026, 2:02 PM 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 23, 2015 · Synced Sep 1, 2026, 2:02 PM EDT
Completed Phase 2 Interventional Results available

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

NCT02188160
View directory record Official record
Conditions
Dry Eye Syndromes, Keratoconjunctivitis Sicca
Interventions
KPI-121, Placebo
Drug
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
11
States / cities
Artesia, California • Mission Hills, California • Rancho Cordova, California + 8 more
Source: ClinicalTrials.gov public record
Updated Jan 5, 2021 · Synced Sep 1, 2026, 2:02 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 1, 2026, 2:02 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 1, 2026, 2:02 PM EDT
Completed Phase 4 Interventional Results available

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

NCT00705159
View directory record Official record
Conditions
Conjunctivitis
Interventions
loteprednol etabonate and tobramycin, loteprednol etabonate, Tobramycin, Vehicle of Zylet
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
1 Week to 6 Years
Enrollment
137 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Erie, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 23, 2015 · Synced Sep 1, 2026, 2:02 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 1, 2026, 2:02 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 1, 2026, 2:02 PM 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 5, 2019 · Synced Sep 1, 2026, 2:02 PM EDT
Completed Phase 3 Interventional Results available

Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.

NCT01475643
View directory record Official record
Conditions
Cataract
Interventions
Loteprednol etabonate, Prednisolones acetate
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
Up to 11 Years
Enrollment
107 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Jun 10, 2019 · Synced Sep 1, 2026, 2:02 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 1, 2026, 2:02 PM EDT
Completed Phase 4 Interventional Results available

Pediatric Zylet Safety and Efficacy Study

NCT00420628
View directory record Official record
Conditions
Chalazion, Hordeolum
Interventions
loteprednol etabonate/tobramycin opthalmic suspension, vehicle
Drug
Lead sponsor
Bausch & Lomb Incorporated
Industry
Eligibility
Up to 6 Years
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Erie, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 6, 2011 · Synced Sep 1, 2026, 2:02 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 1, 2026, 2:02 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 1, 2026, 2:02 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 1, 2026, 2:02 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

NCT03063489
View directory record Official record
Conditions
Eye Pain
Interventions
Loteprednol Etabonate Ophthalmic Gel
Drug
Lead sponsor
Bausch Health Americas, Inc.
Industry
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
6
States / cities
Phoenix, Arizona • Oceanside, California • Miami, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Feb 23, 2017 · Synced Sep 1, 2026, 2:02 PM 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 28, 2025 · Synced Sep 1, 2026, 2:02 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 1, 2026, 2:02 PM 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 25, 2021 · Synced Sep 1, 2026, 2:02 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 1, 2026, 2:02 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 1, 2026, 2:02 PM EDT