Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
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|ClinicalTrials.gov Identifier: NCT02278614|
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : January 23, 2017
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma Ocular Hypertension||Drug: T2347 Drug: Xalacom||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.
Other Name: Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
Active Comparator: Xalacom
Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Other Name: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
- Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye [ Time Frame: Day 84 ]
the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye.
Two relevant time points are considered for this primary criteria: D0 and Day 84.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278614
|Clermont ferrand, France, 63017|
|Principal Investigator:||Ingeborg Stalmans, Professor||Head of the Glaucoma Clinic|