Biotrue® Multi-Purpose Solution

1. Study 640: Results from a 20-investigator multi-site study

2. A study was conducted to determine the comparative pH of different soft contact lens care disinfecting products in comparison to the pH range reported for healthy human tears. The pH range of tears from healthy human eyes is reported to be 7.3 to 7.7 and the mean pH of tears as measured via fluorophotometrics is 7.5 +/- 0.23. The pH of soft contact lens care products was determined to be in the range of 6.7 to 7.8, while Biotrue multi-purpose solution falls within the pH range for healthy human tears at a pH of 7.5, which is reported to be the mean for tears. Three separate lots of Biotrue, CIBA Clear Care, AMO COMPLETE Easy Rub, Alcon OPTI-FREE Express and Alcon OPTI- FREE RepleniSH were compared using a Fisher Scientific accumet excel XL25 pH meter. Five pH measurements for each solution were taken, averaged and evaluated in comparison to the pH range of healthy tears, as determined by Adler’s Physiology of the Eye, Clinical Application 7th edition.

3. In vitro studies evaluated the rate of release of sodium hyaluronate (HA), a conditioning agent in the BPZ02 multi-purpose solution, from both conventional and silicone hydrogel contact lenses over a twenty-hour time period. HA was adsorbed on all traditional and silicone hydrogel contact lenses tested upon soaking in the solution overnight. HA is then released from the lenses throughout at least a twenty hour time period when rinsed with Hank’s balanced salt solution at a rate mimicking tear secretions. The in-vitro performance of BPZ02 multi-purpose solution suggests that it will provide lens conditioning throughout a twenty hour time period.

4. An in vitro lysozyme activity assay was used to determine the ability of BPZ02 to prevent the denaturation of lysozyme, in comparison to multiple marketed multi- purpose solutions. This assay is based on the ability of lysozyme to digest the cell wall of micro-organisms in a suspension. The results indicate that BPZ02 has the ability to stabilize lysozyme in its native form under chemical denaturation conditions that typically denature lysozyme. Statistically significant greater stabilization of lysozyme was observed with BPZ02 compared to competitive multi-purpose solutions and a phosphate buffered saline control.

5. Results of in vitro study following FDA/ISO stand-alone procedure for disinfecting products modified with organic soil added to create a more rigorous test condition. Primary criteria for effective disinfection are defined as a reduction in the number of bacteria by a minimum of 3 logs (99.9%) and a reduction of mold and yeast by a minimum of 1 log (90%) within the recommended disinfection time.

6. A 15-investigator, multi-site clinical study was run in which a total of 291 subjects were enrolled. Eye care professionals rated the performance of Biotrue multi-purpose solution on a number of subjective measures. Subjective assessments were measured using a six-point Likert scale in which 1 = strongly disagree and 6=strongly agree. Results represent reported percentage agreement ratings.

7.  A 14-investigator, multi-site clinical study was run in which a total of 361 subjects were enrolled wearing a variety of silicone hydrogel lenses including Bausch + Lomb PureVision contact lenses, Vistakon ACUVUE Oasys, and CIBA O2 OPTIX or CIBA Night and Day). Subjects were randomly dispensed Biotrue or a control product an approximately equal ratio. Upon study completion (two weeks), assessments were measured using a six-point Likert Scale in which 1=strongly disagree and 6=strongly agree. Results represent percentage agreement ratings.

8. Rah, Marjorie. Et al. Reducing dropout of contact lens wear with Biotrue multipurpose solution. (2014) Clinical Ophthalmology.

9. A total of 300 eye care practitioners asked patients to use Biotrue for at least 3 days resulting in 2855 responses to an online survey.