Who is sponsoring NCT02278614?

NCT02278614 is sponsored by Laboratoires Thea.

What condition does NCT02278614 study?

NCT02278614 studies Open Angle Glaucoma, Ocular Hypertension.

What is the status of NCT02278614?

NCT02278614 is currently COMPLETED.

Last reviewed 2017-03-28 · How we verify

Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.

NCT02278614 Phase 3 COMPLETED Results posted

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).

Details

Lead sponsor	Laboratoires Thea
Phase	Phase 3
Status	COMPLETED
Enrolment	242
Start date	2014-12
Completion	2015-11

Conditions

Open Angle Glaucoma
Ocular Hypertension

Interventions

T2347
Xalacom

Primary outcomes

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 — 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.

Countries

France