Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients

Phase 3

Completed

• Conditions: Glaucoma
• Interventions: Drug: T2345; Drug: Prostaglandin

• Registration Number: NCT01156012
• Lead Sponsor: Laboratoires Thea

Brief Summary

The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2014-11-12
• Results First Submitted QC: 2014-11-12
• Results First Posted: 2014-11-19
• Status Verified: 2014-12
• Last Update Submitted: 2015-01-09
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

Inclusion Criteria

• Adult patients diagnosed with glaucoma

Exclusion Criteria

• Under 18.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2345	T2345	One drop of T2345
Prostaglandin	Prostaglandin	One drop

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP)	Day 0 and Day 84	The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.; * If only one eye is eligible this eye is the worse eye.; * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.; If both eyes have the same IOP at D0 the worse eye is the right eye.

Trial Locations

Locations (1)

Medical Director; 🇫🇷 Clermont-Ferrand, France