Pred Forte (Prednisolone Acetate Ophthalmic) - Summary

PRED FORTE SUMMARY

PRED FORTE^®(prednisolone acetate ophthalmic suspension, USP) 1%

PRED FORTE^® (prednisolone acetate ophthalmic suspension, USP) 1% is a topical anti-inflammatory agent for ophthalmic use.

PRED FORTE^® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

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NEWS HIGHLIGHTS

Published Studies Related to Pred Forte (Prednisolone Ophthalmic)

Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. [2009.01]
PURPOSE: To assess the efficacy and safety of difluprednate ophthalmic emulsion 0.05% (Durezol) 2 or 4 times a day compared with those of a placebo in the treatment of inflammation and pain associated with ocular surgery. SETTING: Twenty-six clinics in the United States... CONCLUSIONS: Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively. There were no serious ocular adverse events. Fewer adverse events were reported in the difluprednate-treated groups than in the placebo group.

Efficacy of methylprednisolone injected into the masseter muscle following the surgical extraction of impacted lower third molars. [2008.03]
The aim of this study was to demonstrate the efficacy of methylprednisolone, as a single 40-mg dose, injected into the masseter muscle upon completion of extraction of impacted lower third molars. A prospective, randomized cross-over study was made of 35 healthy patients... The results obtained show that 40 mg of methylprednisolone injected into the masseter muscle in the immediate postoperative period reduces swelling, trismus and pain.

Methylprednisolone pulse therapy for patients with moderately severe Graves' orbitopathy: a prospective, randomized, placebo-controlled study. [2008.02]
OBJECTIVE: To assess whether methylprednisolone (MP) pulse therapy is efficacious in the treatment of moderately severe Graves' orbitopathy (GO). DESIGN: Prospective, placebo (PL)-controlled, double-blind, randomized study... CONCLUSIONS: In spite of the small number of patients, a significant difference in outcome was observed between MP- and PL-treated patients. We conclude that MP pulse therapy appears to be an effective treatment for active, moderately severe GO.

Clinical comparison of two topical prednisolone acetate 1% formulations in reducing inflammation after cataract surgery. [2007.10]
PURPOSE: To compare the efficacy of two formulations of prednisolone acetate 1% in reducing postoperative inflammation in patients having primary phacoemulsification surgery with IOL implantation... CONCLUSIONS: In this study of routine cataract patients, both prednisolone acetate 1% formulations are comparably effective and safe when administered for the reduction of inflammation after phacoemulsification surgery with IOL implantation.

High-dose intravenous methylprednisolone in recent traumatic optic neuropathy; a randomized double-masked placebo-controlled clinical trial. [2007.09]
BACKGROUND: To compare the effect of high-dose intravenous corticosteroid therapy with placebo in the treatment of recent traumatic optic neuropathy (TON)... CONCLUSIONS: Our study confirms earlier findings that there is no difference in visual acuity improvement between intravenous high-dose corticosteroids and placebo in treatment of recent TNO.

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Clinical Trials Related to Pred Forte (Prednisolone Ophthalmic)

Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis [Completed]
The objective of this study is to investigate if low doses of prednisone TRT, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard prednisone given in the morning. Treatment duration per patient takes 12 months (the double-blind comparative study takes 3 months; 9 months subsequent open treatment on the TRT-medication).

Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy [Completed]
Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this question, valacyclovir was added to prednisone for the treatment of this condition.

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte [Completed]

Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma [Terminated]
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease [Completed]
The aim of this study is to establish associations between blood and urine markers of bone metabolism with histomorphometric changes (changes in the actual bone structure) resulting from short term oral prednisolone treatment in patients with COPD (chronic obstructive pulmonary disease).

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