Study subjects will use betadine saline sinus rinse for period of 6 weeks.

Chronic Rhinosinusitis (Diagnosis)

Povidone Iodine solution 5% (0.5% available iodine) by 3MTM has been specially formulated as a nasal antiseptic. They have shown topical application to be clinically safe, tolerable and to be rapidly bacteriocidal against aerobic gram positive and gram- negative bacteria including methicillin resistant Staphylococcus aureus, methicillin resistant Staphylococcus epidermidis, vancomycin resistant Enterococcus faecium and Enterococcus faecalis (VRE) and yeast (3M study 05-011100,05-011017, 05-011322).

Povidone-Iodine

Budesonide is is provided in nebules (1mg/2cc). Patients will place two nebules of budesonide into the 250mls of saline.

Budesonide

St. Paul's Hospital

Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study

The Efficacy of Topical Povidone - Iodine Rinses in the Management of Biofilm-associated Chronic Rhinosinusitis

differences in Modified Lund-Kennedy (MLK) endoscopic score after 6 weeks of using Povidone-iodine (PVP-I) sinus rinses.

disease specific quality of life questionnaire score (SNOT-22) in recalcitrant/recurrent CRS patients

We will publish final outcomes as scientific paper.

Amin Javer

Clinical Professor

St. Paul's Hospital, Canada

1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.

1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.

Cataract Extraction

Cataract

NETILDEX™ ophthalmic gel

NETILDEX™ eye drops solution

Klinikum Ernst von Bergmann Ophthalmologie

Augenklinik und Poliklinik Ophthalmologie

Azienda Ospedaliero-Universitaria Careggi

Azienda Ospedaliera Fatebenefratelli e Oftalmico

Policlinico Universitario A. Gemelli

Centrul Medical Unirea

Spitalul Universitar de Urgenta Bucuresti

Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction

A Prospective, Multi-center, Controlled, Double-blind Study to Evaluate the Efficacy and Tolerability of a Steroid/Antibiotic Associated Treatment Following Cataract Extraction by Means of Phaco-emulsification

The measurement aims to demonstrate the efficacy of a reduced frequency of administration of NETILDEX™ ophthalmic gel, administered twice daily (b.i.d.), in comparison with NETILDEX™ eye drops solution, administered four times a day (q.i.d.), in the prevention of post-surgery inflammation after cataract extraction by means of phaco-emulsification.

The anti-biogram should be performed according to standard procedure at investigational sites, but including at least the test with Netilmicin and Cefuroxime.

In particular, attention will be focused on the evaluation in treated Patients of: degree of conjunctival hyperemia; lid/corneal edema; ocular discomfort.

SIFI SpA

Sintesi Research Srl

Two treatment arms, test group versus active-comparator (control) group, treated in parallel.

All daily study products will be manufactured in indistinguishable single dose plastic vials, labeled in accordance with hour of administration. In accordance with the double-blind design of the study, daily treatment for patients randomized to group A (NETILDEX™ ophthalmic gel), will be of 2 doses of active treatment and 2 doses of indistinguishable placebo. For blinding purposes, Group B (NETILDEX™ eye drops solution) medications labels will consist in an aluminum envelope for each dose of the daily treatment, containing indistinguishable plastic vials of NETILDEX™ eye drops solution. Tertiary packaging (patient's treatment supply) will be a carton box appropriately labeled, containing 16 secondary packages (aluminum envelopes - each envelope containing 5 vials for each treatment time dose), containing enough plastic vials to allow the patient to complete the whole study treatment.

The study participants will be provided a NeilMed irrigation bottle and instructed to administer 1 packet of ChitoRhino irrigation solution (premixed from manufacturer containing sea salt, Chitosan, and sodium bicarbonate). An informational sheet regarding care and cleaning of the irrigation bottle will be provided during the initial visit. Participants will be instructed to complete up to three nasal saline irrigations daily for 1 month and keep a log to determine compliance. After 1 month of use, the irrigation bottle will be returned at a second study visit.

The study participants will be provided a NeilMed irrigation bottle and instructed to administer nasal saline (250mL of 0.9% sodium chloride) irrigation solution. An informational sheet regarding care and cleaning of the irrigation bottle will be provided during the initial visit. Participants will be instructed to complete up to three nasal saline irrigations daily for 1 month and keep a log to determine compliance. After 1 month of use, the irrigation bottle will be returned at a second study visit.

Sinusitis

ChitoRhino irrigation solution has been developed with chitosan, a natural polysaccharide demonstrated to have antibacterial and antifungal properties. This polysaccharide has beneficial properties in multiple clinic applications including wound healing and post-operative sinus surgery. Chitosan's antimicrobial function develops from its polycationic structure. Chitosan interacts with the negatively charge bacterial wall, leading to disruption and cell lysis.

ChitoRhino irrigation solution

Most nasal irrigations use normal saline (0.9% sodium chloride), which approximates the physiological concentration of plasma in the blood. The saline solution is used to flush the nose of mucous and allergens.

Normal saline

Department of Otolaryngology-Head and Neck Surgery at the University of Virginia Health System

Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions

Patients will be provided an irrigation bottle and instructed to use normal saline for 1 month. Following this period, the saline irrigation bottle will be collected and a bacterial culture of the irrigation bottle will be performed to determine the bacterial contamination present following use.

Patients will be provided an irrigation bottle and instructed to use the ChitoRhino irrigation solution for 1 month. Following this period, the saline irrigation bottle will be collected and a bacterial culture of the irrigation bottle will be performed to determine the bacterial contamination present following use.

polysaccharide/opuch

Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study

Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction

Comparison of Nasal Saline Irrigation Bottle Contamination Between Two Solutions

The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

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