5 results
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
Primary: Safety and tolerability. Secondary: Effectiveness, quality of life, healthcare resource utilisation, work productivity.
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
Primary Objective:To induce clinical response (CDAI decrease from baseline * 100 points) and/or remission(CDAI <150) following 12 weeks of treatment with one of two active doses ofGSK1605786A for qualification of subjects for enrolment into a…
The primary objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) is noninferior to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric glaucoma patients.