MedPath

Bromfenac

Generic Name
Bromfenac
Brand Names
Bromday, Bromsite, Prolensa, Xibrom, Yellox
Drug Type
Small Molecule
Chemical Formula
C15H12BrNO3
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 Non-ophthalmic formulations of bromfenac were withdrawn in the US in 1998 due to cases of severe liver toxicity.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

PRevention of Macular EDema After Cataract Surgery

Phase 3
Completed
Conditions
Cystoid Macular Edema
Diabetes Mellitus
Cataract
Interventions
First Posted Date
2013-01-24
Last Posted Date
2017-04-14
Lead Sponsor
Maastricht University Medical Center
Target Recruit Count
1127
Registration Number
NCT01774474
Locations
🇦🇹

Hospital of the Brothers of Saint John of God, Vienna, Austria

🇧🇪

University Hospital Antwerp, Edegem, Belgium

🇳🇱

Academic Medical Center, Amsterdam, Netherlands

and more 13 locations

Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification

Phase 2
Completed
Conditions
Phacoemulsification Cataract Surgery
Cataract
Interventions
First Posted Date
2012-08-06
Last Posted Date
2018-10-30
Lead Sponsor
Laboratorios Sophia S.A de C.V.
Target Recruit Count
160
Registration Number
NCT01657266
Locations
🇲🇽

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico

Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects

Phase 3
Completed
Conditions
Ocular Inflammation
Interventions
Other: DuraSite Vehicle
First Posted Date
2012-04-13
Last Posted Date
2021-11-19
Lead Sponsor
Sun Pharmaceutical Industries Limited
Target Recruit Count
268
Registration Number
NCT01576952

Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

Phase 1
Completed
Conditions
Inflammation
Cataract
Interventions
First Posted Date
2012-02-17
Last Posted Date
2019-10-16
Lead Sponsor
Laboratorios Sophia S.A de C.V.
Target Recruit Count
35
Registration Number
NCT01535443
Locations
🇲🇽

Unidad Medica "Grupo Pediátrico", Guadalajara, Jalisco, Mexico

A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease

Phase 2
Withdrawn
Conditions
Dry Eye Disease
Interventions
First Posted Date
2011-11-23
Last Posted Date
2021-11-19
Lead Sponsor
Sun Pharmaceutical Industries Limited
Registration Number
NCT01478555

Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

Completed
Conditions
Myopia
Interventions
First Posted Date
2011-11-21
Last Posted Date
2016-05-03
Lead Sponsor
Virdi Eye Clinic
Target Recruit Count
20
Registration Number
NCT01475877
Locations
🇺🇸

Virdi Eye Clinic and Laser Vision Center, Rock Island, Illinois, United States

Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery

Phase 2
Completed
Conditions
Cataract
Interventions
Drug: Bromday™
First Posted Date
2011-07-04
Last Posted Date
2021-11-19
Lead Sponsor
Sun Pharmaceutical Industries Limited
Target Recruit Count
60
Registration Number
NCT01387464

Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Phase 3
Completed
Conditions
Pain
Inflammation
Cataract
Interventions
First Posted Date
2011-06-07
Last Posted Date
2014-05-06
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
440
Registration Number
NCT01367249
Locations
🇺🇸

ISTA Pharmaceuticals, Inc., Irvine, California, United States

Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

Phase 4
Completed
Conditions
Inflammation
Pseudophakia
Interventions
First Posted Date
2011-03-08
Last Posted Date
2020-10-28
Lead Sponsor
Toyos Clinic
Target Recruit Count
23
Registration Number
NCT01310127

A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

Phase 3
Completed
Conditions
Dry Eye Syndrome
Interventions
First Posted Date
2010-09-30
Last Posted Date
2020-09-04
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
840
Registration Number
NCT01212471
Locations
🇺🇸

ISTA Pharmaceuticals, Inc., Irvine, California, United States

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