Bromfenac

Generic Name: Bromfenac

Brand Names: Bromday, Bromsite, Prolensa, Xibrom, Yellox

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₂BrNO_₃

CAS Number: 91714-94-2

Unique Ingredient Identifier: 864P0921DW

Background: Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Ophthalmic NSAIDs are becoming a cornerstone for the management of ocular pain and inflammation. Their well-characterized anti-inflammatory activity, analgesic property, and established safety record have also made NSAIDs an important tool for optimizing surgical outcomes. Non-ophthalmic formulations of bromfenac were withdrawn in the US in 1998 due to cases of severe liver toxicity.

Indication: For the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Associated Conditions: Eye Pain, Ocular Inflammation

Clinical Trials

Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

Phase 4

Completed

Conditions: Cataracts

Interventions: Drug: Xibrom, and Optive
Drug: Xibrom and Pred Forte

First Posted Date: 2008-06-17

Last Posted Date: 2009-06-10

Lead Sponsor: Bp Consulting, Inc

Target Recruit Count: 200

Registration Number: NCT00698724

Locations: 🇺🇸
St. Luke's Cataract and Laser institute, Tarpon Springs, Florida, United States

Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

Phase 4

Completed

Conditions: Acute Pseudophakic Cystoid Macular Edema

Interventions: Drug: Ketorolac
Drug: Bromfenac
Drug: Diclofenac

First Posted Date: 2008-01-16

Last Posted Date: 2009-03-19

Lead Sponsor: Bp Consulting, Inc

Target Recruit Count: 166

Registration Number: NCT00595543

Locations: 🇺🇸
Soll Eye Associates, Philadelphia, Pennsylvania, United States

Efficacy and Safety of Bromfenac Ophthalmic Solution

Phase 2

Completed

Conditions: Cataract Surgery

Interventions: Drug: bromfenac ophthalmic solution

First Posted Date: 2008-01-04

Last Posted Date: 2013-02-15

Lead Sponsor: Bausch & Lomb Incorporated

Target Recruit Count: 568

Registration Number: NCT00585975

Locations: 🇺🇸
ISTA Pharmaceuticals, Inc., Irvine, California, United States

Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Phase 4

Completed

Conditions: Dry Eye Disease
Ocular Comfort

Interventions: Drug: bromfenac
Drug: ketorolac

First Posted Date: 2007-08-23

Last Posted Date: 2009-02-19

Lead Sponsor: Florida Eye Microsurgical Institute

Target Recruit Count: 42

Registration Number: NCT00520260

Locations: 🇺🇸
Florida Eye Microsurgical Institute, Boynton Beach, Florida, United States

Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser

Phase 1

Conditions: Diabetic Macular Edema

First Posted Date: 2007-06-25

Last Posted Date: 2007-06-25

Lead Sponsor: Ophthalmic Consultants of Boston

Target Recruit Count: 10

Registration Number: NCT00491166

Locations: 🇺🇸
Ophthalmic Consultants of Boston, Boston, Massachusetts, United States

Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema.

Phase 2

Withdrawn

Conditions: Cystoid Macular Edema

Interventions: Drug: Refresh Plus
Drug: Bromfenac (Xibrom)

First Posted Date: 2007-02-22

Last Posted Date: 2016-07-04

Lead Sponsor: Johns Hopkins University

Registration Number: NCT00438243

Locations: 🇺🇸
The Johns Hopkins Hospital, Baltimore, Maryland, United States

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis

Phase 3

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Placebo
Drug: Bromfenac

First Posted Date: 2007-01-17

Last Posted Date: 2013-03-14

Lead Sponsor: Bausch & Lomb Incorporated

Target Recruit Count: 90

Registration Number: NCT00423007

Locations: 🇺🇸
ISTA Pharmaceuticals, Inc., Irvine, California, United States

Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Phase 3

Completed

Conditions: Pain
Inflammation

Interventions: Drug: bromfenac ophthalmic solution
Drug: placebo comparator

First Posted Date: 2006-06-06

Last Posted Date: 2013-02-15

Lead Sponsor: Bausch & Lomb Incorporated

Target Recruit Count: 522

Registration Number: NCT00333918

Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery

Phase 3

Completed

Conditions: Postoperative Complications
Cataract

Interventions: Drug: Placebo
Drug: Bromfenac

First Posted Date: 2005-09-20

Last Posted Date: 2013-03-14

Lead Sponsor: Bausch & Lomb Incorporated

Target Recruit Count: 527

Registration Number: NCT00198445

Locations: 🇺🇸
Eye Care of San Diego, San Diego, California, United States
🇺🇸
Cornea Consultants, Boston, Massachusetts, United States
🇺🇸
Ophthalmic Consultants of Long Island, Rockville Centre, New York, United States

and more 36 locations

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