Clinical Data
The Phase 3 randomized, double-masked, parallel-arm, placebo-controlled clinical trial enrolled 96 subjects and was conducted across 6 sites in the U.S. using Ora, Inc.’s modified Conjunctival Allergen Challenge (Ora-CAC®) Model. The primary efficacy measure for this trial was ocular itching on Day 8 at 3 minutes, 5 minutes and 7 minutes post-challenge and included subjects with seasonal and perennial allergens. The trial’s primary endpoint was ocular itching measured on a 5-point scale (0 to 4) at three pre-specified time points on Day 8 (PM), 1 week after insertion of DEXTENZA. DEXTENZA-treated subjects demonstrated a statistically significant (p<0.0001) change in ocular itching from baseline at all three pre-specified time points (Table 1). An assessment of the secondary endpoint of ocular itching at all other visits (Day 7, Day 8 (AM), Day 8 (PM, 10 minutes following exposure), Day 14, and Day 15 (AM and PM)) also showed that DEXTENZA-treated subjects had lower itching scores than vehicle-treated subjects at 3 minutes, 5 minutes, 7 minutes and 10 minutes post-CAC (p<.05 for all 21 time points except Day 7 at 3 minutes).