Sight Sciences said today that it launched a clinical trial of its Omni eye surgery device in sequential, minimally invasive glaucoma procedures.
Menlo Park, Calif.-based Sight Sciences said the 130-patient Gemini study is designed to evaluate the use of Omni in consecutive MIGS procedures involving transluminal viscoelastic delivery and trabeculotomy at 12 months. The single-arm trial’s primary outcomes are change in mean unmedicated diurnal intraocular pressure and change in mean number of IOP-lowering drugs. Secondary outcomes include percent of eyes with a more than 20% reduction in unmedicated diurnal IOP and percent of eyes with unmedicated diurnal IOP between 6mmHg and 18mmHg. The safety endpoints are the rate of ocular adverse events and best corrected visual acuity, according to ClinicalTrials.gov.
The estimate primary completion date is August 2020, with final completion slated for December next year.
“Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with performing multiple MIGS procedures during one surgery. Our goal of intervening earlier in the disease stage with multiple mechanisms of action is to generate the most efficacy possible while maintaining the optimal safety profile of MIGS,” Dr. Steve Vold, who performed the study’s first procedures, said in prepared remarks. “The Omni surgical system targets the three points of resistance in the conventional outflow pathway; this medical technology has the potential to become a leading option in the MIGS space.”
“Sight Sciences is committed to building upon a strong foundation of scientific evidence to help inform surgeons’ clinical decisions and help them select technologies that are best suited for their individual patients,” added chief medical officer Dr. Reay Brown. “We look forward to further confirming – via this large-scale, prospective, multicenter trial – that our sophisticated technology offers a compelling alternative to traditional treatments.”