However, regarding conjunctival redness on day 8, the drug was not superior to placebo, Dr. Feulner explained. Differences between the groups were significant on only 2 of the 3 time points after CAC, i.e., at 15 and 20 minutes (P ≤ 0.0419), which failed to meet the criteria for clinically meaningfulness at the 7-, 15-, and 20-minute time points with differences of -0.26, -0.32 and -0.41, respectively.
There were no differences between the groups regarding the secondary endpoints.
Regarding safety, a total of 4 adverse events developed in 3 subjects treated with the dexamethasone insert and a total of 7 adverse events developed in 4 subjects treated with placebo. All adverse events were considered mild or moderate, with most affecting the eye.
The most common of these was increased lacrimation, which was reported by 1 subject in the dexamethasone insert group and 2 subjects in the placebo group. No serious adverse events developed in either groups, and no subjects withdrew from the study because of an adverse event.
“Based on these results, (dexamethasone insert) is effective for treating ocular itching but not conjunctival redness associated with allergic conjunctivitis,” Dr. Feulner said. “Treatment with (the dexamethasone insert) is safe and well-tolerated.”