A Double Masked Minimization in Ophthalmology Study

Phase II study conducted with a dose-escalation minimization

A phase II ophthalmology study was conducted with a dose-escalation minimization to evaluate the safety, tolerability and efficacy of a treatment in reduction of intraocular pressure in subjects with ocular hypertension or primary open-angle Glaucoma. Double Masked Minimization in Ophthalmology Study: first the kits were randomized to eye (OD or OS) and then the randomization system (ID-net) performed a stratified minimization on treatment (active or placebo). The dose escalation was managed by using different cohorts automatically closed by the system once the number of expected patients was reached. Our randomization system is flexible and can adapt to studies with a very complex design. It is supported by a 24/7 Help Desk which allows an optimal interaction with Sponsors and Sites during the study.