To test the efficacy of the Swype Shield when used by people, a study was conducted from February to April 2011. Participants for this study, 103 in total, were recruited from hospital staff at two hospitals as well as from outpatient physical therapy treatment facilities. To assure compliance with clinical protocols, participants were instructed to apply the Swype Shield to their nose three times a day for 6-8 weeks, and submit weekly surveys documenting their usage, tolerability, and health. 83% of the weekly surveys reported use of Swype Shield 2 or more times per day that week, a high compliance rate for a prophylactic product.
Using a very generous definition of a viral upper respiratory illness (VURI), any nasal congestion or cough of moderate or greater severity and at least one other symptom of mild or greater severity, it was found that 2.2% of participants contracted a VURI despite using Swype Shield 2 or 3 times/day that week. For comparison sake, historical data indicates that the average American adult contracts 2-3 VURI per cold season. Based on this data, predicted numbers of VURI would be 5.6%-8.4%. Using the middle estimate of 6.9%, the use of Swype Shield resulted in a 68% reduction in incidence of VURI (p<0.001).
A secondary objective of the study evaluated the tolerability of Swype Shield, and during the study 5% of the participants reported minor side effects. The primary side effect was irritation, which typically decreased when participants used less of the Swype Shield during applications. No major side effects were reported.
Given the complexity of factors which contribute to VURI, most of which are out of the control of the study sponsor and the study participants, the results of this study which demonstrate 83% of participants were willing to use the nasal antiviral gel appropriately to help prevent illness, and that such use resulted in an almost 70% reduction in the incidence of VURI compared to predicted incidence, are very impressive. In fact, literature review has not revealed any other intervention (including hand washing studies) that has demonstrated this degree of compliance and success in the prevention of VURI.
Swype Shield has been subjected to extensive testing to demonstrate that the product is both safe and effective.
After selecting the two active ingredients for Swype Shield, we had the independent laboratory, MicroBioTest, perform dilution studies to determine the lowest concentration of each ingredient required to effectively neutralize viruses.
Once the optimal combination of actives was determined, extensive in vitro testing was conducted. The first test demonstrated that the combination of active ingredients in Swype Shield resulted in a clinically significant reduction of all 25 cold and flu viruses tested, including 15 serotypes of Rhinovirus, 3 serotypes of Adenovirus, Coronavirus, Parainfluenza virus, Respiratory Syncytial Virus, Human Influenza Virus A & B, Avian Influenza, and Swine Influenza (H1N1). Results are presented in Table 1.
Further in vitro testing then demonstrated that this combination of active ingredients resulted in >99% reduction of all 27 bacteria and yeast tested, including MRSA, which is known to colonize in the nose. The panel of organisms tested against were chosen due to their being common hospital and community pathogens. Results are presented in Table 2, and demonstrate that the active ingredients in Swype Shield are highly effective at neutralizing a broad array of bacteria as well as common yeasts.
Finalizing Swype Shield
To create a topical gel specially formulated for the nares, the active ingredients were added to a corn-oil based natural moisturizer with a natural thickener. The resulting formulation was over 99% natural and invisible when applied, as well as free from ingredients that are harmful to the nares (e.g., alcohol and zinc). The formulation passed industry-standard patch testing and bacterial and fungal challenge testing to demonstrate tolerability for topical application and effectiveness of the preservative, respectively.