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ClinicalTrials.gov public records Last synced Oct 1, 2026, 10:04 PM EDT

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Showing 1–24 of 24 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert Clear all
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 11, 2023 · Synced Oct 1, 2026, 10:04 PM EDT
Terminated Phase 4 Interventional Results available

Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery

NCT04200651
View directory record Official record
Conditions
Glaucoma, Cataract
Interventions
Dexamethasone Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp
Drug
Lead sponsor
The New York Eye Surgery Center
Other
Eligibility
21 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated Jan 31, 2024 · Synced Oct 1, 2026, 10:04 PM EDT
Not listed Phase 4 Interventional Accepts healthy volunteers

DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures

NCT05116345
View directory record Official record
Conditions
Glaucoma Following Surgery
Interventions
DEXTENZA, Topical Dexamethasone
Drug
Lead sponsor
Brian Jerkins, MD
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2023
U.S. locations
1
States / cities
Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Nov 11, 2021 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Phase 4 Interventional

The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1

NCT05143281
View directory record Official record
Conditions
Cataract
Interventions
Dexamethasone 0.4 MG [Dextenza]
Drug
Lead sponsor
Grene Vision Group
Other
Eligibility
65 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
2
States / cities
Wichita, Kansas
Source: ClinicalTrials.gov public record
Updated Jul 6, 2023 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

NCT05023304
View directory record Official record
Conditions
Cataract
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Topical prednisolone acetate
Drug
Lead sponsor
Vance Thompson Vision
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Sioux Falls, South Dakota
Source: ClinicalTrials.gov public record
Updated Aug 17, 2025 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Phase 4 Interventional Results available

Assessing Dextenza Insert After SMILE Procedure

NCT04380857
View directory record Official record
Conditions
Post Procedural Infection
Interventions
Dexamethasone ophthalmic insert 0.4 mg, Topical Prednisolone Acetate Ophthalmic Drops
Drug
Lead sponsor
William Wiley, MD
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Brecksville, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 6, 2023 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

NCT04396990
View directory record Official record
Conditions
Refractive Surgery
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone
Drug
Lead sponsor
Vance Thompson Vision
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Sioux Falls, South Dakota
Source: ClinicalTrials.gov public record
Updated Jul 30, 2024 · Synced Oct 1, 2026, 10:04 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 24, 2026 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Phase 4 Interventional

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

NCT05626478
View directory record Official record
Conditions
Corneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome, CME - Cystoid Macular Edema
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp, Prolensa 0.07% Ophthalmic Solution
Drug
Lead sponsor
Nicole Fram M.D.
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Feb 20, 2026 · Synced Oct 1, 2026, 10:04 PM EDT
Not listed Phase 4 Interventional Accepts healthy volunteers

DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery

NCT04281862
View directory record Official record
Conditions
Refractive Surgery
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone
Drug
Lead sponsor
Vance Thompson Vision
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
West Fargo, North Dakota
Source: ClinicalTrials.gov public record
Updated Feb 24, 2020 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers Results available

DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

NCT05620901
View directory record Official record
Conditions
Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome, Retinal Detachment Rhegmatogenous, Retinal Detachment Exudative, Retinal Detachment Traction
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Pred Forte
Drug
Lead sponsor
Lejla Vajzovic, MD, FASRS
Other
Eligibility
3 Years to 17 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2025
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Pharmacokinetics of Aqueous Dexamethasone

NCT04667507
View directory record Official record
Conditions
Pharmacokinetics, Aqueous Dexamethasone, Inflammatory Cytokine Response
Interventions
Dexamethasone Ophthalmic implant
Drug
Lead sponsor
Frank A. Bucci, Jr., M.D.
Other
Eligibility
55 Years and older
Enrollment
102 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Wilkes-Barre, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 21, 2024 · Synced Oct 1, 2026, 10:04 PM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

The PRIME Study: A Randomized, Controlled, Prospective Study

NCT04549935
View directory record Official record
Conditions
Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema
Interventions
Dextenza, Topical Prednisolone
Drug
Lead sponsor
Vance Thompson Vision - MT
Other
Eligibility
22 Years to 75 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
Bozeman, Montana
Source: ClinicalTrials.gov public record
Updated Sep 16, 2020 · Synced Oct 1, 2026, 10:04 PM EDT
Terminated Phase 4 Interventional Accepts healthy volunteers Results available

Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye

NCT04498468
View directory record Official record
Conditions
Dry Eye
Interventions
Sustained Release Dexamethasone, 0.4 mg, E-Caprolactone-L-Lactide copolymer (PCL) punctal plug
Drug · Other
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 100 Years
Enrollment
77 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2023
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 15, 2024 · Synced Oct 1, 2026, 10:04 PM EDT
Not listed Phase 4 Interventional

INtravitreal and Aqueous Dexamethasone Levels After DEXtenza

NCT04529512
View directory record Official record
Conditions
Ocular Disease Requiring Surgery
Interventions
DEXTENZA®
Drug
Lead sponsor
Nathan Steinle
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
3
States / cities
Paso Robles, California • San Luis Obispo, California • Santa Maria, California
Source: ClinicalTrials.gov public record
Updated Jan 29, 2021 · Synced Oct 1, 2026, 10:04 PM EDT
Recruiting Phase 4 Interventional

Dextenza in the Post-op Management of Vitreoretinal Surgeries

NCT04371445
View directory record Official record
Conditions
Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain, Post-Operative Inflammation
Interventions
Dexamethasone Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp
Drug
Lead sponsor
The Cleveland Clinic
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Oct 1, 2026, 10:04 PM EDT
Completed No phase listed Observational

A Retrospective Review of DEXTENZA 0.4 mg inseRt Following Corneal Transplant or Cataract Surgery

NCT04975971
View directory record Official record
Conditions
Anterior Chamber Inflammation, Ocular Pain, Corneal Edema, Corneal Defect, Penetrating KeratoPlasty, Nuclear Cataract, Cortical Cataract, Cataract Senile
Interventions
Dextenza 0.4Mg Ophthalmic Insert
Drug
Lead sponsor
Nicole Fram M.D.
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jul 26, 2021 · Synced Oct 1, 2026, 10:04 PM EDT
Not listed Phase 4 Interventional

Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

NCT04592081
View directory record Official record
Conditions
Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
Interventions
Dextenza 0.4Mg Ophthalmic Insert
Drug
Lead sponsor
Kerry Assil, MD
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Beverly Hills, California
Source: ClinicalTrials.gov public record
Updated Oct 19, 2020 · Synced Oct 1, 2026, 10:04 PM EDT
Completed Phase 4 Interventional

DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery

NCT04462523
View directory record Official record
Conditions
Vitreo-Retinal Surgery
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Topical Prednisolone
Drug
Lead sponsor
Patrick R. Oellers, MD
Network
Eligibility
Not listed
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
1
States / cities
Liverpool, New York
Source: ClinicalTrials.gov public record
Updated Jun 15, 2023 · Synced Oct 1, 2026, 10:04 PM EDT
Withdrawn Phase 4 Interventional

Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes

NCT04728646
View directory record Official record
Conditions
Graft Vs Host Disease
Interventions
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use, Regular dissolvable intracanalicular plug
Drug · Device
Lead sponsor
Massachusetts Eye and Ear Infirmary
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jan 5, 2022 · Synced Oct 1, 2026, 10:04 PM EDT
Terminated Phase 4 Interventional

Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections

NCT04563299
View directory record Official record
Conditions
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
Interventions
Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate
Drug
Lead sponsor
Retina Vitreous Associates of Florida
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
St. Petersburg, Florida
Source: ClinicalTrials.gov public record
Updated Feb 22, 2023 · Synced Oct 1, 2026, 10:04 PM EDT
Terminated Phase 4 Interventional

Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

NCT04464629
View directory record Official record
Conditions
Retinal Detachment
Interventions
Dextenza, Prednisolone Acetate
Drug
Lead sponsor
Midwest Eye Institute
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Aug 16, 2023 · Synced Oct 1, 2026, 10:04 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 24, 2023 · Synced Oct 1, 2026, 10:04 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 13, 2022 · Synced Oct 1, 2026, 10:04 PM EDT