NCT02278614

Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	T2347	T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.
DRUG	Xalacom	Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-10-30
• Last updated: 2017-04-28
• Results posted: 2017-01-23

Locations

1 site across 1 country: France