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Sustained-release dexamethasone decreased ocular itching, conjunctival redness in phase 2 trial
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Patients treated with a single dose of sustained-release dexamethasone for allergic conjunctivitis demonstrated significantly lower ocular itching and conjunctival redness scores compared with subjects who received placebo over 6 weeks, according to an Ocular Therapeutix press release.
The prospective, multicenter, randomized, double-masked phase 2 clinical trial evaluated 68 patients treated with OTX-DP (sustained-release dexamethasone) for reactions to a variety of allergens over 42 days. The primary outcome was a decrease in ocular itching and conjunctival redness at 14 days after administration.
Those treated with the dexamethasone punctum plug had significantly lower ocular itching and conjunctival redness scores compared with the placebo group at days 14, 28 and 42 after insertion.
Patients with the plug had a mean difference of more than 0.5 units on a five-point scale at day 14 for ocular itching and conjunctival redness. However, there was no mean difference of 1 unit during most of the time points for either of the symptoms.
A phase 3 clinical trial of the dexamethasone plug is underway for the treatment of postoperative inflammation and pain.