Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

开始日期2019-12-10

申办/合作机构

Silverstein Eye Centers

[+1]

NCT03886779 / Completed临床4期

Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (nepafenac Ophthalmic Suspension) 0.3% QD with extra (pulse) dose on day of surgery for Treatment of Ocular Inflammation Associated with Cataract Surgery

开始日期2013-10-30

申办/合作机构

Silverstein Eye Centers

[+2]

100 项与 Silverstein Eye Centers 相关的临床结果

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2023-09-01·Current eye research

Effects of Punctal Occlusion on Ocular Itching and Conjunctival Redness Associated with Allergic Conjunctivitis.

Article

作者: Silverstein, Steven M ; Gurses Ozden, Rabia ; Meier, Edward J ; Bauskar, Aditi ; Sato, Michelle A ; Depperschmidt, Kennedy ; Vantipalli, Srilatha ; Blender, Nysha ; Goldstein, Michael H ; Dai, Stella

PURPOSEPunctal occlusion using punctal plugs has been successfully used to treat the signs and symptoms of dry eye disease. However, the effects of punctal occlusion on the symptoms of allergic conjunctivitis (AC) have been less well documented. There is some concern among clinicians that punctal occlusion may make signs/symptoms of allergic conjunctivitis worse by trapping allergens on the eye. The objective of this post hoc analysis was to address this question and thus assess the effect of punctal occlusion alone on ocular itching and conjunctival redness associated with AC.METHODSThis was a pooled post hoc analysis of three randomized, double-blind, placebo insert-controlled clinical trials in subjects with AC. Enrolled subjects were generally healthy adults with ocular allergies and a positive skin test reaction to perennial and/or seasonal allergens. The study used a modified version of the traditional conjunctival allergen challenge (CAC) model, which included multiple, repeated allergen challenges following placement of the intracanalicular insert. Subjects were rechallenged on Days 6, 7 and 8; Days 13, 14 and 15; and Days 26, 27 and 28.RESULTSThe data set included 128 subjects that were administered placebo. Baseline mean (SD) ocular itching and conjunctival redness scores were 3.52 (0.44) and 2.97 (0.39), respectively. On post-insertion Days 7, 14 and 28, mean itching scores were 2.62, 2.26 and 1.91, respectively, representing 26%, 36% and 46% itching reductions, respectively (p < 0.001). On Days 7, 14 and 28, mean conjunctival redness scores were 1.98, 1.90, and 2.08, respectively, representing 33%, 36%, and 30% redness reductions, respectively (p < 0.001).CONCLUSIONSBased on this post hoc pooled analysis, punctal occlusion with a resorbable hydrogel intracanalicular insert did not worsen ocular itching or conjunctival redness in this patient population.

2019-12-01·Ophthalmology and Therapy3区 · 医学

Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical “Pulse” Dose

3区 · 医学

ArticleOA

作者: Silverstein, Steven M

INTRODUCTIONThis small pilot study is the first direct comparison of the currently marketed formulations of bromfenac (0.07% solution) and nepafenac (0.3% suspension) using identical dosing regimens and including an extra pre-surgical "pulse" dose in patients undergoing cataract surgery.METHODSAdults scheduled for unilateral phacoemulsification with intraocular lens implantation were randomly assigned to bromfenac 0.07% or nepafenac 0.3%, each given once-daily 1 day prior to surgery, on the day of surgery plus an extra dose 1 h before surgery, and for 14 days after surgery. Assessments included summed ocular inflammation score (SOIS), visual acuity (VA), and retinal thickness measured via optical coherence tomography.RESULTSThe study population included 49 patients (bromfenac, n = 24; nepafenac, n = 25). The percentage of patients with a SOIS = 0 (no cells or flare) at post-surgical day 15 (primary efficacy endpoint) was statistically similar between the bromfenac (57.1%) and nepafenac (50.0%) treatment groups (intent-to-treat with last observation carried forward) (P = 0.6318). The proportions of patients with an SOIS of 0 at days 3 and 8 were significantly (P < 0.05) higher in the bromfenac group (23.8 and 52.4%, respectively) versus the nepafenac group (0.0 and 20.8%, respectively). Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness. Rescue medication (typically difluprednate) was given on or before day 15 to 13 patients in each treatment group (bromfenac, 54.2%; nepafenac, 52.0%). There were no adverse events considered to be related to either treatment.CONCLUSIONSThe results of this small pilot study suggest that once-daily bromfenac 0.07% produces similar benefits with regard to postsurgical inflammation, VA, and retinal thickness as once-daily nepafenac 0.3%, and possibly has a faster onset of anti-inflammatory action, when compared using identical dosing regimens.FUNDINGBausch & Lomb Incorporated.TRIAL REGISTRATIONNCT03886779.

2011-09-01·Current Medical Research and Opinion4区 · 医学

Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain

4区 · 医学

Article

作者: Sadri, Ehsan ; Peace, James H. ; Cable, Melissa G. ; Gow, James A. ; Chandler, Simon P. ; Klier, Sharon M. ; Silverstein, Steven M. ; McNamara, Timothy R. ; Fong, Raymond

OBJECTIVETo evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.09% dosed once daily for the treatment of ocular inflammation and pain following cataract extraction with posterior chamber intraocular lens implantation.METHODSA total of 455 subjects (455 study eyes: 230 bromfenac, 225 placebo) were enrolled in two randomized double-masked, placebo-controlled, clinical trials at 64 ophthalmology clinics in the United States. Subjects were randomized to receive either bromfenac 0.09% or placebo dosed once daily. Dosing began 1 day before cataract surgery (Day -1), continued on day of surgery (Day 0), and for 14 days following surgery. Evaluations were completed on Days 1, 3, 8, 15 and 22. The primary efficacy endpoint was cleared summed ocular inflammation score (SOIS) by Day 15. The secondary efficacy endpoint was the number of subjects who were pain-free at Day 1.RESULTSThe bromfenac 0.09% group was significantly higher compared to the placebo group in the primary endpoint of the proportion of subjects who had cleared ocular inflammation by Day 15 (P < 0.0001). The mean SOIS for the bromfenac 0.09% group was lower than the placebo group at Days 3, 8, 15, and 22 (P < 0.0001). More bromfenac 0.09% subjects were pain free at Days 1, 3, 8, and 15 (P < 0.0001). Fewer subjects in the bromfenac 0.09% group withdrew from the clinical trials due to lack of efficacy at Day 15 (P < 0.0001). Fewer adverse events were reported in the bromfenac 0.09% group than the placebo group. Limitations included advanced age, female predominance, and surgical nuances among cataract surgeons, making cross-trial comparisons difficult.CONCLUSIONSBromfenac ophthalmic solution 0.09% dosed once daily is clinically safe and effective for the treatment of ocular inflammation and the reduction of ocular pain associated with cataract surgery.

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2024-10-15

·PRNewswire

LiveOnNY Unveils State-of-the-Art "Donate Eight Simulation Center," Advancing Excellence in Organ Donor Care

The groundbreaking Simulation Center will train LiveOnNY clinical and field staff and educate the public on the lifesaving process of organ donation. NEW YORK, Oct. 15, 2024 /PRNewswire/ -- LiveOnNY, the federally designated organ procurement organization (OPO) for the New York Metro region, is proud to announce the Donate Eight Simulation Center at LiveOnNY. The unveiling took place during a special ribbon-cutting ceremony at LiveOnNY's headquarters in Long Island City, Queens. Continue Reading LiveOnNY unveils new state-of-the-art Donate Eight Simulation Center that will train LiveOnNY clinical and field staff and educate the public on the lifesaving process of organ donation Thanks to the generous financial support of Donate Eight and the LiveOnNY Foundation, the cutting-edge Simulation Center will elevate training and education for both Clinical Operations staff and the public, focusing on the lifesaving process of organ donation. The center includes a fully equipped mock operating room and ICU, designed to train employees in donor case management within a controlled, immersive environment. "We are deeply grateful to Donate Eight and the LiveOnNY Foundation for their invaluable support in making this vision a reality," said LiveOnNY CEO and President Leonard Achan, RN, MA, ANP. "This center will help ensure that our staff and the community are fully equipped with the knowledge and skills needed to carry out our mission of giving hope and saving lives. Our organ donor heroes and their families are our top priority, and this simulation center will allow us to continue upholding donor care excellence, ensuring their legacies live on through the gift of life." By simulating critical scenarios—such as navigating organ donor operating rooms and critical care donor management settings, engaging with family members, and seeking authorization for organ donation—the center complements the hands-on learning experience of shadowing senior staff during real donor hospital cases. Staff will have the opportunity to develop crucial conversation skills and experience the complexities of approaching families in crisis to discuss the lifesaving gift of organ donation. "We founded Donate Eight over a decade ago, and what we're most proud of is that we did it purely out of altruism," said Scott Salmirs, CEO and President of ABM Industries and founder of Donate Eight. "As members of the buildings industry, we wanted to give back to our city. We are honored to partner with LiveOnNY on this lifesaving mission and deeply grateful to the LiveOnNY Foundation team for their dedication. We also thank LiveOnNY President and CEO Leonard Achan for his exceptional leadership, which has resulted in saving more than 3,000 lives over the past three years." The Donate Eight Simulation Center is also designed as an educational tool for high school students, nursing and medical students, elected officials, and members of the public. By offering insight into the intricacies of organ donation, the center aims to raise awareness and understanding of the importance of organ and tissue donation, and the extraordinary effort involved in saving and changing lives through these gifts. "This center embodies what we at Donate Eight wanted to do from the start – provide education and raise awareness about the critical need for organ donation in New York," said Bill Dacunto, Executive Vice President of Silverstein Properties, Chairperson of LiveOnNY Foundation and member of Donate Eight. "The Board of Donate Eight is proud to be part of the Simulation Center, it is such an achievement." ABOUT LIVEONNY LiveOnNY is a nonprofit, federally designated organ procurement organization (OPO) dedicated to saving lives, providing comfort, and strengthening legacies through organ, eye, and tissue donation. The OPO, which was established in 1978, serves a culturally and ethnically diverse population of 13 million residents in New York City, Nassau, Suffolk, Westchester, Orange, Putnam, Dutchess, and Rockland. Working closely with donor hospital and transplant centers, LiveOnNY coordinates organ, eye, and tissue donation for transplant, educates the public and healthcare professionals about donation, and promotes the importance of signing up on the National or New York State Donate Life Registry. LiveOnNY is a member of the United Network for Organ Sharing (UNOS), which oversees the organ transplant waiting list in the U.S. For more information, please visit LiveOnNY.org ABOUT DONATE EIGHT Donate Eight is a non-profit organization founded by members of the New York City Real Estate, Building Management and Building Service community in response to the immediate need to increase organ donation education and awareness to help save more lives. Learn more about Donate Eight here. Donate Eight is the founding and primary fundraising organization for LiveOnNY Foundation – the philanthropic arm of LiveOnNY. SOURCE LiveOnNY WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED