Asepticys LLC announced the successful completion of its multisite clinical trial for a new contact lens solution designed for rapid disinfection.
The company submitted a 510k application to the FDA, Asepticys said in a press release.
Rebecca Metzinger, MD, professor of ophthalmology at Tulane University School of Medicine and chief of ophthalmology at the Southeast Louisiana Veterans Healthcare System, helped design the clinical protocols for evaluating the TriFlect technology in the contact lens solution. She told Primary Care Optometry News that the trials took place at 12 different sites and involved more than 320 patients.
The solution’s TriFlect technology provides multi-action, broad-spectrum, 1-hour disinfection of bacteria, viruses, fungi and protozoa, Metzinger told PCON. No rinsing is necessary after disinfection, but “rubbing is recommended to loosen residue that may also build up on the contact lens,” she said. It is intended to be used with any contact lens requiring regular disinfection.
“As clinicians, we all need to up our game to prevent serious eye infections, and TriFlect technology provides us with a new tool to combat the continuing evolution of dangerous pathogens,” Metzinger said. “Asepticys is already looking ahead and developing additional new products using TriFlect technology to combat eye infections.” – by Nancy Hemphill, ELS, FAAO
Disclosure: Metzinger designed the clinical trial protocols for Asepticys.