Article Date: 9/1/2010

Putting Bio-inspired Lens Care to the Test
HIGHLIGHTS FROM AROUND TABLE DISCUSSION

Putting Bio-inspired Lens Care to the Test

A premarket product performance evaluation reveals practitioners' and patients' impressions.

Drs. Anderson, Cedrone, DePaolis and Giedd were among the eyecare professionals who participated in a 2-week product performance evaluation of Biotrue multipurpose contact lens solution. Patients were adapted, daily wear, single-vision lens wearers who were using a variety of commercially available lens care products and habitual lenses — both hydrogel and silicone hydrogel — representative of currently marketed products. Testing took place in normal practice environments and the study was approved by an institutional review board with patients consenting to participate. Biotrue was fully branded, and its benefits were communicated to patients in the usual manner for each practice. After the patients used Biotrue at home, they were asked to complete an online survey outside of their practitioner's office to help ensure a higher level of objectivity. When the patients returned to the practices for followup, the practitioners evaluated ocular health, lens fit and lens cleanliness. Following the exit appointments, practitioners completed a survey of their impressions.

PATIENTS' PERCEPTIONS

Of the 400 patients in this study, 94% indicated their overall opinion of Biotrue multi-purpose solution was good to excellent. Comfort and moistness earned high marks among patients, specifically:

● 90% of patients rated overall comfort as good to excellent
● 96% rated initial comfort upon lens application as good to excellent
● 84% stated Biotrue provided continuous comfort throughout the day
● 89% of patients rated overall moistness as good to excellent
● 98% rated moistness upon lens application as good to excellent.

The product performed equally well with hydrogel and silicone hydrogel lenses.

These data were no surprise to the roundtable panelists, who observed similar reactions from patients in their offices. "Patients remarked how comfortable their lenses were upon application," Dr. Cedrone says. "That was the dominant positive comment. They also mentioned that comfort was maintained throughout the day."

Dr. Anderson noted the statistics related to initial comfort and comfort throughout the day are helpful takehome points for patients. "Those are compelling data and excellent information to relay to patients," he says. "It's information they can grasp and understand, particularly when comfort is what they're hoping to get."

CLINICAL EVALUATIONS

While patients reported good to excellent comfort with Biotrue multi-purpose solution, clinicians are particularly interested in a product's cleaning and disinfecting efficacy as evidenced by a patient's vision and ocular health, as well as microbiological efficacy testing. As Table 1 shows, the clinicians who participated in the 2-week performance evaluation of Bioture were satisfied with clinical metrics associated with lens cleanliness, comfort and health. CLS

Clinical Trials Provide a High Level of Confidence
Prior to obtaining FDA clearance, a new lens care product undergoes rigorous testing. Biotrue multi-purpose contact lens solution was tested in six multicenter clinical trials conducted by 83 clinical investigators over a period of 2-1/2 years. A total of 1,560 patients used Biotrue, and data were collected from 7,212 eye examinations (3,088 hydrogel, 4,124 silicone hydrogel eye visits), representing more than 72,000 exposures.
Investigators graded corneal infiltrates, bulbar injection, limbal injection, corneal staining and tarsal conjunctival abnormalities. Total occurrences of graded findings greater than grade 2 at the follow-up visits were less than 0.1% in each category, and no adverse events† were reported with the use of Biotrue multi-purpose solution in combination with hydrogel or silicone hydrogel lenses.
The panelists agreed these objective measures of overall ocular health reflect and validate the subjective reports from the collective study of their patients, 91% of whom stated Biotrue was gentle to their eyes.
"These data are very impressive and give clinicians the confidence that Biotrue has been rigorously studied," Dr. DePaolis says. "The number of clinical investigators, the diversity of the study population and the sheer number of slit lamp examinations reported in this metaanalysis of clinical studies give us a high level of confidence that Biotrue is well tested."
According to Dr. Giedd, "These statistics, reinforced by the number of eye visits and the number of eyes studied, unequivocally show this is a biocompatible product. The studies show how exceptionally well-tolerated, wellaccepted and compatible Biotrue is. I have no concerns about recommending it to my patients.
"As doctors, we don't just look at transient superficial corneal staining. We consider the whole picture. The data set shows me those are healthy eyes," Dr. Giedd concludes.
Dr. DePaolis concurs. "For me, there's no one slit lamp finding that either validates or indicts a solution," he said. "Rather, I believe we must look at all slit lamp findings in the context of how the patient is doing. After all, this is what our patients expect of us: a thorough assessment and an educated, professional recommendation." According to Dr. Anderson, "These data show that the average clinician looking at patients should not expect to see problems. In other words, the examination should be straightforward, and the doctor shouldn't see complications, which makes it simple. You can expect your patients to do well with this product."
†adverse events are defined as sight-threatening conditions and include complications such as corneal ulcers



Contact Lens Spectrum, Issue: September 2010