ULTRA Contact Lenses Granted FDA Approval for Extended Wear
The new indication will allow wearers to use the contacts for up to 6 nights and 7 days continuously.
The US Food and Drug Administration (FDA) has approved an extended wear indication for Bausch + Lomb’s ULTRA contact lenses. The new indication will allow wearers to use the contacts for up to 6 nights and 7 days continuously.
The application to the FDA was filed in November 2017, based on a 12-month, controlled, parallel group, masked, randomized trial including 34 sites in the United States.
Additionally, results of an online survey with patients that wore their contacts for ≥7 days and wore their lenses for ≥8 hours a day (n = 485) showed that 90% of patients agreed that the contacts were still comfortable after the 8+ hours. The survey questions were top 3-box scores (% Strongly Agree, Agree, Slightly Agree) on a 6-point agreement scale, with a margin of error +/- 2.4%.
The product, originally presented in the US in 2014, is currently the only brand that utilizes Bausch + Lomb’s MoistureSeal technology, which allows for 95% of moisture maintenance for up to 16 hours, according to company data.
“We are proud of today’s regulatory milestone, which signifies that Bausch + Lomb ULTRA contact lenses provide additional options for eye care professionals to help meet the lifestyle demands and preferences of their patients,” John Ferris, MBA, the general manager of US Vision Care at Bausch + Lomb, said in a statement. “With this latest indication for Bausch + Lomb ULTRA, we continue to deliver on our promise to provide a wide range of innovative solutions that help address the evolving needs of patients and eye care professionals alike.”
The ULTRA group of contact lenses incorporates polyvinylpyrrolidone for greater wettability, a high Dk/t, or oxygen transmissibility (163) and low modulus (70) elasticity. The Bausch + Lomb ULTRA type contact lenses are also available for patients with astigmatism and presbyopia, extending the lens parameter offering to +6.00D to -9.00D in 0.25D steps (in 0.50D steps above -6.00D) in cylinder powers of -0.75D, -1.25D, -1.75D, -2.25D and axes of 10°-180˚ (in 10˚ steps). It received FDA clearance for those indications in November 2017.
“Bausch + Lomb ULTRA contact lenses are a trusted and preferred lens option for my practice and my patients,” Ben Gaddie, OD, of the Gaddie Eye Centers in Louisville, Kentucky, said in a statement. “Now with the extended wear indication, I can offer these lenses to patients who prefer a longer wearing schedule as part of their lifestyle.”
Patients who use extended wear contacts are at higher risk of risk of microbial keratitis and other potentially vision-threatening adverse events compared to users of daily wear contact lenses. Patients that experience discomfort, excessive tearing, vision changes, or redness of the eye should immediately remove the lenses and promptly contact his or her eye care practitioner.
