Pooled analysis of CFS scores and safety data
CFS
ADVERSE EVENT, INTRAOCULAR PRESSURE
Efficacy results for CFS and safety data from the vehicle-controlled periods of both studies were pooled into the following treatment arms:Pooled low-dose group (Pooled high-dose group (Pooled vehicle group (Safety assessments for both studies included laboratory data, best-corrected distance visual acuity (BCDVA), and systemic and ocular adverse event (AE) reporting, including intraocular pressure (IOP) assessment. Change from baseline in CFS scores by dose group was assessed using an ANCOVA model including baseline CFS score and Study as covariates. Missing data at day 28 was replaced by the last post-treatment observation available (last observation carried forward method).