A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery
The primary objective was to demonstrate that two days of treatment with 0.5% prednisolone acetate eye-drops after cataract surgery are superior to vehicle in reducing the flare in the anterior chamber of the operated eye.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Multi-Center, Randomized, Double Masked, Vehicle Controlled Phase IV Study to Compare the Efficacy, Ocular Safety and Tolerability of a Two Day Treatment With Eye Drops (0.5% Prednisolone Acetate, One Drop Four Times Per Day) in Patients With Intraocular Inflammation After Cataract Surgery, Followed by an Open Label Observational Period of 12 Days|
- Primary efficacy parameter was the anterior chamber flare of the operated eye, measured by a KOWA laser cell flare meter.
- The secondary objectives were to demonstrate that two days treatment with 0.5 % prednisolone acetate eye drops:
- are superior to vehicle regarding corneal edema and bulbar conjunctival hyperemia,
- are safe regarding intraocular pressure (IOP), visual acuity and frequency of AEs and SAEs,
- are well tolerated regarding ocular discomfort.
|Study Start Date:||August 2004|