Sight Sciences Announces First Patient Treated in TRIDENT European Trial to Evaluate the OMNI® Surgical System in Pseudophakic Eyes with Open-Angle Glaucoma
Novel trial design will compare safety and effectiveness outcomes for the OMNI Surgical System and the iStent inject® in lowering intraocular pressure (IOP) as a standalone treatment option without concomitant cataract surgery.
Excerpt from the Press Release:
MENLO PARK, Calif., March 24, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform care and improve patients’ lives, today announced that the first patient has been treated in the novel TRIDENT clinical trial, designed to demonstrate the OMNI® Surgical System with higher volume as a safe and effective standalone treatment option, compared to implantation of iStent inject®, in lowering IOP in adult patients with open-angle glaucoma. With glaucoma, elevated IOP is the leading risk factor for the development and progression of the disease.
The TRIDENT study is a prospective, randomized, multicenter, comparative trial evaluating the safety and effectiveness outcomes, including IOP reduction, for pseudophakic eyes (eyes which had previously undergone cataract surgery) in three study arms: (1) canaloplasty alone using the OMNI Surgical System, (2) sequential canaloplasty followed by trabeculotomy using the OMNI Surgical System and (3) implantation of two trabecular microbypass canal implants using iStent Inject. The OMNI study arms will use a next-generation OMNI Surgical System that dispenses a higher volume of viscoelastic fluid than the currently marketed OMNI Surgical System. Study objectives include analyzing canaloplasty and trabeculotomy outcomes combined in one procedure and canaloplasty alone. This superiority trial will enroll 459 subjects who will be randomized in an equal allocation ratio (1:1:1) to the three study arms and followed for 12 months after surgery. To the best of our knowledge, TRIDENT is the largest standalone MIGS clinical trial ever initiated.
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