CyclASol 0.1% for dry eye disease showed superiority to vehicle in change from baseline on corneal fluorescein staining in its first pivotal clinical trial, Novaliq announced in a press release.
The phase 2b/3 randomized, double-masked, vehicle-controlled ESSENCE trial included 328 patients at nine U.S. clinical sites and evaluated the primary efficacy endpoint of improvement in total corneal fluorescein staining over vehicle at 4 weeks, with continued dosing over 3 months.
Improvement of total corneal fluorescein staining at day 29 was statistically significant with CyclASol over vehicle (P =
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