CLINICAL TRIALS PROFILE FOR XIBROM
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All Clinical Trials for XIBROM
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00377546 ↗ | Comparison of Vitreous Levels of Acular LS 0.04%, Xibrom 0.09%, and Nevanac 0.1% | Completed | Innovative Medical | Phase 4 | 1969-12-31 | To compare the penetration of three different NSAIDs. |
| NCT00438243 ↗ | Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema. | Withdrawn | Johns Hopkins University | Phase 2 | 2008-05-01 | This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of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. The investigators want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients. |
| NCT00698724 ↗ | 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 Sta | Completed | Bp Consulting, Inc | Phase 4 | 2008-06-01 | 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. |
| NCT00758199 ↗ | Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery | Completed | Bp Consulting, Inc | Phase 4 | 2008-07-01 | 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. |
| NCT00758628 ↗ | Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema. | Completed | Bp Consulting, Inc | Phase 4 | 2008-08-01 | : The objective of this study is to determine if bromfenac reduces diabetic macular edema (DME) as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the working-aged population in the United States. 60% of patients with Type-II DM, and nearly all with Type-I DM progress to Diabetic Retinopathy (DR) in twenty years. Diabetic Macular Edema is the principal cause of vision loss in DR. Approximately 50% of patients with DME will experience a loss of >=2 lines of best-corrected visualacuity (VA) after 2 years of follow-up. The pathogenesis of DME is multifactorial and complex, but intervention stratagem have tended to be singular. Photocoagulation laser applied directly to leaking microaneurysms and a "grid" of laser has been the mainstays of treatment since the publication of the Early Treatment Diabetic Retinopathy Study (ETDRS). This landmark clinical trial was an NIH sponsored, multicenter, controlled study that demonstrated efficacy of laser for diabetic macular edema. It also demonstrated that 20% of patients did not respond. Recent efforts to improve the results are focusing on pharmaceutical interventions injected into the vitreous cavity. The route of administration and lack of substantiated efficacy are problematic. |
| NCT00828477 ↗ | Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT) | Completed | Bp Consulting, Inc | Phase 4 | 2009-01-01 | The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT. |
| NCT01001806 ↗ | A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification | Completed | Allergan | Phase 4 | 2009-10-01 | Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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