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In order to receive a 510-K Medical Device clearance from the FDA, the product must demonstrate bioequivalence with the predicate devices. All Hypochlorous acid products that have received 510-K clearance and have identical bacterial kill rates using the USP51 test and identical principle compositions. All Hypochlorous acid products are manufactured similarly. Chlorine in water splits into two forms, Hypochlorous acid and Hypochlorite Ion. At the high pH the chlorine provided by bleach contains a maximum of Hypochlorite Ion. The chlorine produced by electrolyses or chemical reaction contains a maximum concentration of Hypochlorous acid.
How much of each is present in a chlorine solution is totally dependent upon the pH of the solution. As pH rises, less Hypochlorous Acid and more Hypochlorite Ion is in the solution. As the pH rises, less germ killing power is available. The ideal pH of a disinfecting chlorine solution is a pH of 6-7 which is where most Hypochlorous acid products range.
Shelf-life of Hypochlorous acid formulas used in eyelid care is extremely important. For example, the shelf-life of NovaBay’s Avenova™ is 3 years. However, once the product is opened, its equilibrium shifts, chlorine gas is released and it degrades into saline after 30 days. Therefore, one bottle of Avenova™ only lasts one month. Compare this to OCuSOFT® HypoChlor™ that has an 18 month shelf-life and stability either opened or unopened. Since we believe that OCuSOFT® HypoChlor™ should only be used as an adjunct to eyelid cleansers and for severe cases only, OCuSOFT® HypoChlor™’s 2oz. bottle could last a patient for 3-6 months. Once the eyelid irritation is under control within the first 2 weeks of treatment with OCuSOFT® Lid Scrub® Plus and HypoChlor™, then the patient can switch to a low cost maintenance regimen of OCuSOFT® Lid Scrub® Original.
Currently, a minimum order of Avenova™ on-line through NovaBay’s website is 3 bottles at $30 each in 1.33 oz. Annual treatment with Avenova™ would cost at least $360. Compare this with the recommended therapy of OCuSOFT® HypoChlor™ ($21.95), OCuSOFT® Lid Scrub® PLUS® ($20) for the first two weeks of treatment, then OCuSOFT® Lid Scrub® Original monthly thereafter ($20 for a 90 day supply 7.25 oz. bottle) equals $121.00 per year. This is a savings to the patient of 66% using the OCuSOFT preferred therapy.