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Showing 1–24 of 50 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Loteprednol Clear all
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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 May 13, 2026 · Synced Sep 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

The DEPOT Study (Dry Eye Prescription Options for Therapy)

NCT04911361
View directory record Official record
Conditions
Dry Eye
Interventions
Dexamethasone
Drug
Lead sponsor
Research Insight LLC
Industry
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
3
States / cities
Hemet, California • Laguna Hills, California • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jan 2, 2022 · Synced Sep 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 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 2, 2026, 1:04 PM EDT