The U.S.-based Phase 3 clinical trial is a multi-center, 1:1 randomized, double-masked, placebo-controlled trial slated to enroll 80 patients. The study will evaluate Dextenza 0.4mg to treat allergic conjunctivitis and ocular itching versus a placebo vehicle puncture plug using Ophthalmic Research Associates’s modified Conjunctival Allergen Challenge Model, according to the company.
“We are pleased to be advancing Dextenza for allergic conjunctivitis,” president and CEO Antony Mattessich said in a news release. “We believe Dextenza has the potential to replace the current standard of care eye drops with a one time, long-acting, seasonal therapy for the treatment of AC. With the start of this Phase 3 trial, following the recent approval of Dextenza in the U.S. by the Food and Drug Administration (FDA) for the treatment of ocular inflammation and pain following ocular surgery, we are clearly focused on demonstrating Dextenza’s potential as a platform product for Ocular Therapeutix both in the surgical and outpatient settings.”
The clinical trial will assess the effect of the device compared with a placebo on allergic reactions using successive allergen challenges in a 30-day period. The primary efficacy endpoint is ocular itching following Dextenza insertion at multiple time points in the time period.
Dextenza is an ocular insert that is designed to release 0.4 mg of dexamethasone to relieve pain after ophthalmic surgery. It can deliver drugs for up to 30 days after treatment in a physician’s office.
Ocular Therapeutix launched the Dextenza device commercially in the U.S. in early July this year.