Aldeyra Therapeutics Announces First Patient Enrolled in the RENEW Phase 3 Clinical Trial for Dry Eye Disease
"Based on the positive results from our Phase 2b dry eye disease clinical trial, in which reproxalap demonstrated early onset and broad activity, we are pleased to initiate the RENEW Phase 3 trial," commented
The RENEW Trial is a two-part, multi-center, randomized, double-masked, parallel-group, vehicle-controlled, adaptive Phase 3 clinical trial evaluating the efficacy of reproxalap ophthalmic solution (0.25%) vs. vehicle in 400 patients with moderate-to-severe dry eye disease. Results from the first part of the trial will confirm the dosing regimen and sample size for the second part. The co-primary endpoints of the trial will be ocular dryness and fluorescein nasal region ocular staining in pre-specified moderate to severe patient subsets analyzed over twelve weeks of therapy using Mixed effects Model Repeated Measures (MMRM).
More information about the RENEW trial is available on www.clinicaltrials.gov (NCT03879863).
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