Ocular begins patient enrolment in dexamethasone Phase II trial for dry eye disease

Dexamethasone is being developed for administration as a one-time, bioresorbable intracanalicular plug for drug release to the ocular surface for up 30 days.

A total of 40 patients exhibiting signs and symptoms of dry eye disease are expected to be enrolled at two sites in the US.

Ocular Therapeutix president and CEO Amar Sawhney said: "This Phase II exploratory study is designed to assist us in identifying the subgroup of patients that may benefit from a low-dose, Sustained Release Dexamethasone therapy for treatment of inflammatory dry eye disease, allowing us to refine clinical trials for this indication in the future.

"Dry eye is one of the most common ophthalmic disorders affecting approximately 20 million people in the US, and is expected to rise with an aging population."

The prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled trial is designed to evaluate the safety and efficacy of OTX-DP in these patients.

During the trial, patients will initially be administered a placebo vehicle plug for 30 days to establish a baseline for the investigational drug treatment.

The company said that patients who respond to the placebo plug only in treatment of their dry eye disease will be excluded from the trial and those who continue to exhibit symptoms of dry eye during the initial 30 days will be qualified for enrollment in the treatment phase of the trial.

Following examination, eligible patients will be randomized to either OTX-DP or a placebo vehicle plug.

The trial’s primary efficacy measures will include corneal and conjunctival staining, tear osmolarity, tear film break-up time, presence of the plug, ease of product use and visualization, and resorption of the plug following therapy.