Conditions: Open Angle Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 242
Healthy volunteers: no

Brief summary:
The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

Detailed description:
Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients

Arms:
arm 1: T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops arm 2: Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops

Interventions: intervention 1: T2347 intervention 2: Xalacom
Intervention descriptions: intervention 1: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers. intervention 2: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.

Protocol document: