STATROL SUMMARY
Statrol®
neomycin and polymyxin B
sulfates ophthalmic solution, USP
STATROL® (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, USP) is a sterile ophthalmic drug combining two antibacterials in ointment form. Each gram of ointment contains: Active: Neomycin Sulfate equivalent to 3.5 mg Neomycin base, Polymyxin B Sulfate equal to 10,000 polymyxin B units.
STRATOL Ophthalmic Ointment is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute meibomianitis and dacryocystitis.
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NEWS HIGHLIGHTS
Clinical Trials Related to Statrol (Neomycin / Polymyxin B Ophthalmic)
Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment [Recruiting]
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in
about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the
nostrils twice daily for 5 days is the current standard of care for treatment to clear this
bacteria. This research study is designed to determine the rate of clearance of this
bacteria in healthcare workers who are carriers when using triple antibiotic ointment
instead of mupirocin ointment.
Tissue Characterization in Teeth Treated With a Regeneration Protocol [Not yet recruiting]
The purpose of the investigators study is to characterize the composition of the hard and
soft tissues present in root canals of teeth previously diagnosed with necrotic pulps and
incomplete root formation and treated with a triple antibiotic regeneration protocol. The
investigators hypothesis is that treatment of teeth with necrotic pulps and immature apices
with triple antibiotic paste will stimulate continued root formation by the deposition of
dentin at the root apices. The primary outcome measure will be histological identification
of mineralized tissue and adherent cells in the apical third of these teeth.
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale [Active, not recruiting]
This is a prospective multicenter clinical study to evaluate the safety and effectiveness of
an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent
foramen ovale (PFO).
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum [Recruiting]
The purpose of this study is to determine the functional performance of the Middle Turbinate
Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in
which the Principal Investigator determines clinical relevance.
Rhinogenic Headache Improvement After Nasal Operation [Recruiting]
Objective: To determine the efficacy of surgical correction of intranasal mucosal contact
points in improving quality of life and decreasing medication use in patients with
rhinogenic headaches.
Significance: Chronic, debilitating headaches that resist maximal medical treatment by
various headache specialists are sometimes linked to structural anomalies within the nose
that exert pressure on apposing mucosal surfaces. A number of otolaryngologists have
reported success in alleviating rhinogenic headaches with contact point correction surgery.
This practice is supported by anecdotal reports along with retrospective and observational
studies; however, a prospective study with an appropriate surgical control group has not
been conducted. Because the specific effect of contact point correction has not yet been
differentiated from the placebo effect of surgery itself, many headache specialists are
reluctant to recommend surgical evaluation for their patients. To demonstrate the efficacy
of contact point correction surgery to both the headache and otolaryngology communities -
and thus, to make this treatment option more widely available to rhinogenic headache
sufferers - a randomized controlled trial is needed.
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