prednisolone ophthalmic / Generic mfg. - LARVOL DELTA

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (clinicaltrials.gov) - P4 | N=50 | Completed | Sponsor: Nicole Fram M.D. | Active, not recruiting ➔ Completed

Trial completion • Cataract • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Pain

Nodular Scleritis and Pyoderma Gangrenosum Associated with Active Ulcerative Colitis: A Case Report. (PubMed, Case Rep Ophthalmol) - "As the scleritis did not respond to 0.1% betamethasone eye drops and prednisolone ophthalmic ointment, oral glucocorticoids were initiated, leading to significant improvement in skin and ocular inflammation as well as clinical remission of UC. UC and pyoderma gangrenosum are rare causes of nodular scleritis. This rare case underscores the importance of reviewing a patient's systemic disease history and recognizing systemic symptoms to identify the underlying cause of scleritis and initiate appropriate treatment in a timely manner."

Journal • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Keratitis • Ocular Inflammation • Ophthalmology • Pain • Pyoderma Gangrenosum • Scleritis • Ulcerative Colitis • Vasculitis • CRP

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (clinicaltrials.gov) - P4 | N=50 | Active, not recruiting | Sponsor: Nicole Fram M.D. | Recruiting ➔ Active, not recruiting | N=100 ➔ 50 | Trial completion date: Jun 2024 ➔ Apr 2025 | Trial primary completion date: Jun 2024 ➔ Apr 2025

Enrollment change • Enrollment closed • Surgery • Trial completion date • Trial primary completion date • Cataract • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Pain

Dextenza in the Post-op Management of Vitreoretinal Surgeries (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: The Cleveland Clinic | Enrolling by invitation ➔ Recruiting | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Enrollment status • Surgery • Trial completion date • Trial primary completion date • Inflammation • Ocular Inflammation • Pain

SUSTAIN: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (clinicaltrials.gov) - P4 | N=25 | Terminated | Sponsor: The New York Eye Surgery Center | Completed ➔ Terminated; COVID-19 challenges to recruitment

Surgery • Trial termination • Cataract • Glaucoma • Ophthalmology

Formulation and evaluation of beta-cyclodextrin versus hydroxypropyl-beta-cyclodextrin additives to a 1% prednisolone ophthalmic formulation (ASHP 2023) - No abstract available

Ophthalmology

SUSTAIN: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (clinicaltrials.gov) - P4 | N=25 | Completed | Sponsor: The New York Eye Surgery Center | Recruiting ➔ Completed | N=40 ➔ 25 | Trial completion date: Dec 2023 ➔ Jul 2023

Enrollment change • Surgery • Trial completion • Trial completion date • Cataract • Glaucoma • Ophthalmology

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery (clinicaltrials.gov) - P4 | N=36 | Completed | Sponsor: Nicole Fram M.D. | Recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Jan 2023

Surgery • Trial completion • Trial completion date • Inflammation • Ocular Inflammation • Ophthalmology • Pain • Transplantation

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Nicole Fram M.D. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2024 ➔ Jun 2024 | Initiation date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Enrollment open • Surgery • Trial completion date • Trial initiation date • Trial primary completion date • Cataract • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Pain

DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses (clinicaltrials.gov) - P4 | N=13 | Completed | Sponsor: Prism Vision Group | Recruiting ➔ Completed | N=30 ➔ 13 | Trial completion date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: Sep 2021 ➔ Dec 2022

Enrollment change • Surgery • Trial completion • Trial completion date • Trial primary completion date • Cataract • Ophthalmology

SUSTAIN: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: The New York Eye Surgery Center | Trial completion date: Apr 2023 ➔ Dec 2023 | Trial primary completion date: Feb 2023 ➔ Sep 2023

Surgery • Trial completion date • Trial primary completion date • Cataract • Glaucoma • Ophthalmology

Dextenza in the Post-op Management of Vitreoretinal Surgeries (clinicaltrials.gov) - P4 | N=30 | Enrolling by invitation | Sponsor: The Cleveland Clinic | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Surgery • Trial completion date • Trial primary completion date • Immunology • Inflammation • Ocular Inflammation • Pain

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Nicole Fram M.D. | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Mar 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pain • Transplantation

Safety and Effectiveness of Drop-free Small Incision Cataract Surgery (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Visualiza | Trial completion date: Aug 2022 ➔ Nov 2022 | Trial primary completion date: Aug 2022 ➔ Nov 2022

Trial completion date • Trial primary completion date • Cataract • Glaucoma • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

SUSTAIN: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: The New York Eye Surgery Center | Trial completion date: Apr 2022 ➔ Apr 2023 | Trial primary completion date: Feb 2022 ➔ Feb 2023

Trial completion date • Trial primary completion date • Cataract • Glaucoma • Ophthalmology

Dextenza in the Post-op Management of Vitreoretinal Surgeries (clinicaltrials.gov) - P4 | N=30 | Enrolling by invitation | Sponsor: The Cleveland Clinic | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Immunology • Inflammation • Ocular Inflammation • Pain

Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study (clinicaltrials.gov) - P4; N=20; Active, not recruiting; Sponsor: Sight Medical Doctors PLLC; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Nov 2021 ➔ Apr 2022

Trial completion date • Trial primary completion date • Immunology • Inflammation • Ophthalmology • Pain

Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes (clinicaltrials.gov) - P4; N=200; Not yet recruiting; Sponsor: Baylor Research Institute

New P4 trial • Cataract • Diabetes • Metabolic Disorders • Ophthalmology

Steroids up the risk of organ damage in SLE (RheumNow) - P=NA, N=1,707; "Damage accrural was independently associated with damage the time-adjusted mean SLEDAI-2K (AMS) (HR 1.32), mean PGA score (HR 1.05, p=0.0012), mean prednisolone dose, age at enrolment, and ethnicity (Asian vs non-Asians). Nearly 9% had an AMS score of 0 (no disease activity), and two-thirds were on steroids and taking a mean prednisolone dose of 2 mg/day...This study is novel in that it shows that glucocorticoid use was independently associated with irreversible organ damage and not just a confounder for disease activity and organ damage."

Clinical data