OMNIPRED SUMMARY
OMNIPRED™ (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension.
OMNIPRED (prednisolone OPHTHALMIC) is indicated for the following:
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
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NEWS HIGHLIGHTS
Published Studies Related to Omnipred (Prednisolone Ophthalmic)
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.
Comparative evaluation of megadose methylprednisolone with dexamethasone for treatment of primary typical optic neuritis. [2007.09]
AIM: To compare the efficacy of intravenous methylprednisolone and intravenous dexamethasone on visual recovery and evaluate their side-effects for the treatment of optic neuritis... CONCLUSION: Intravenous dexamethasone is an effective treatment for optic neuritis. However, larger studies are required to establish it as a safe, inexpensive and effective modality for the treatment of optic neuritis.
Clinical Trials Related to Omnipred (Prednisolone Ophthalmic)
A Comparison of Three Different Formulations of Prednisolone Acetate 1% [Recruiting]
The Efficacy of Three Months-Prednisolone Therapy for Chronic Eosinophilic Pneumonia [Recruiting]
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in
the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration
may be as effective as 6 months-therapy.
Prednisolone Pharmacokinetics in Severe Asthma [Recruiting]
The purpose of the study is to evaluate whether severe asthmatic subjects have abnormal
prednisolone absorption, and how this might affect the anti-inflammatory effects of
prednisolone.
The aims of the study are
1. to compare the effect of high dose prednisolone on clinical and physiological responses
2. to determine the effect of long-term oral prednisolone therapy on corticosteroid
responsiveness and prednisolone pharmacokinetics
3. to measure the effect of high dose prednisolone for 14 days on p38 MAPK activity, GR
translocation and activation of NF-kB
4. to validate an easier method of measuring corticosteroid insensitivity using whole
blood, and a spot prednisolone serum level as a measure of adherence to prednisolone
therapy
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE) [Recruiting]
Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted
immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the
variable effects on immune homeostasis of the background medications that must be continued,
in most study designs, in these flare-prone patients.
Purpose of Study: This study will purposefully study a population equivalent to the placebo
group of typical trials in SLE. Patients will enter the trial in mild-moderate flare, be
treated with depomedrol, and background treatments will be withdrawn. Biomarkers at entry on
various medications will be compared to biomarkers after steroid efficacy with background
medications withdrawn. Depomedrol usually slowly wears off over one to three months.
Patients will be closely observed, with serial biomarkers drawn at monthly intervals or,
immediately at the time of a new flare. Those patients who do develop new flares during the
course of the next year (maximal participation time) will donate blood samples for
biomarkers (flaring on tapering or absent depomedrol effect) and will then be immediately
treated as deemed appropriate, exiting the study. The study will end when 50 patients have
met this endpoint. A control population of matched, healthy individuals will donate blood
once for the same biomarker studies.
Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation [Recruiting]
This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up
to 5 sites. The purpose of this study is to determine how effective the combination of Pred
Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the
prevention of eye allergies. Study subjects will be randomized to one of the following:
- FOV1101-00 concentration 1 and Pred Mild®
- FOV1101-00 concentration 2 and Pred Mild®
- Vehicle of FOV1101-00 and Pred Forte®
- Vehicle of FOV1101-00 and Vehicle of FOV1101-00
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