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Xibrom (Bromfenac Sodium Ophthalmic) - Summary

 



XIBROM SUMMARY

XIBROM (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Xibrom contains 1.035 mg bromfenac sodium equivalent to 0.9 mg bromfenac free acid.

XIBROM ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.


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NEWS HIGHLIGHTS

Published Studies Related to Xibrom (Bromfenac Ophthalmic)

Comparison of efficacy of bromfenac sodium 0.1% ophthalmic solution and fluorometholone 0.02% ophthalmic suspension for the treatment of allergic conjunctivitis. [2009.06]
AIMS: Bromfenac sodium (BF) 0.1% was compared with fluorometholone (FML) 0.02% for the treatment of seasonal allergic conjunctivitis when concomitantly used with disodium cromoglycate (DSCG) 2.0%... CONCLUSIONS: Bromfenac sodium for allergic conjunctivitis was effective, with efficacy equivalent to that of FML when used with DSCG.

Effect of bromfenac ophthalmic solution on ocular inflammation following cataract surgery. [2009.05]
PURPOSE: This study compared the post-cataract surgery anti-inflammatory effects of topical treatment with 0.1% bromfenac, 0.1% betamethasone or both on postoperative anterior chamber inflammation and corneal swelling... CONCLUSIONS: There were no significant differences in anti-inflammatory effects among the three treatments. These findings suggest that bromfenac is as effective as betamethasone in minimizing inflammatory reactions after cataract surgery.

Topical bromfenac 0.09% vs. ketorolac 0.4% for the control of pain, photophobia, and discomfort following PRK. [2009.02]
PURPOSE: To compare the efficacy of two topical nonsteroidal anti-inflammatory drugs with regards to the control of pain, burning, photophobia, foreign body sensation, and epithelial healing rates in patients who underwent photorefractive keratectomy (PRK)... CONCLUSIONS: No significant differences were observed between the use of bromfenac (twice daily) and ketorolac (four times daily) with regard to postoperative PRK discomfort and safety when combined with postoperative measures such as cold BSS and a bandage contact lens.

Ocular pharmacokinetics of a single dose of bromfenac sodium ophthalmic solution 0.1% in human aqueous humor. [2008.12]
PURPOSE: The aim of this study was to evaluate the ocular pharmacokinetics of a single dose of bromfenac sodium ophthalmic solution 0.1% in subjects undergoing routine cataract surgery with intraocular lens implantation... CONCLUSIONS: Pharmacokinetic modeling, based upon samples collected over 240 min after a single dose of bromfenac sodium ophthalmic solution 0.1% suggests that aqueous-humor concentrations remain at clinically effective levels (above its IC(50) value for COX-2) for over 12 h. Based upon this rationale, these results supported clinical trials that demonstrated the efficacy of twice-daily dosing of bromfenac sodium ophthalmic solution 0.1% to manage patients with postoperative ocular pain and inflammation.

Comparison of ketorolac 0.4% and bromfenac 0.09% at trough dosing: aqueous drug absorption and prostaglandin E2 levels. [2008.09]
PURPOSE: To compare aqueous drug concentrations and prostaglandin E(2) (PGE(2)) levels in patients treated with ketorolac 0.4% and bromfenac 0.09% at trough dosing. SETTING: Private practice, Wilkes-Barre, Pennsylvania, USA... CONCLUSIONS: Higher aqueous levels and greater PGE(2) inhibition were observed in cataract surgery patients treated with ketorolac 0.4% than in patients treated with bromfenac 0.09% at trough dosing. These findings suggest that ketorolac 0.4% administered 4 times a day may provide better control of prostaglandin-mediated inflammation than bromfenac 0.09% administered twice a day.

more studies >>

Clinical Trials Related to Xibrom (Bromfenac Ophthalmic)

Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema. [Active, not recruiting]
This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) called "macular edema" that occurs after cataract surgery. Swelling in the retina can lead to blurry vision.

The most commonly used treatment is eyedrops that decrease inflammation and may help stop some of the swelling. We want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients.

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 [Recruiting]
To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.

Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery [Recruiting]
The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.

Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT) [Not yet recruiting]
The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects [Completed]
The purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery.

more trials >>

Page last updated: 2009-10-20

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