Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Drug: Prostaglandin; Drug: T2345

• Registration Number: NCT01494753
• Lead Sponsor: Laboratoires Thea

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Results First Submitted: 2014-11-12
• Results First Submitted QC: 2014-12-22
• Results First Posted: 2015-01-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria

• Any ocular hypertension other than chronic open angle glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prostaglandin	Prostaglandin	One drop.
T2345	T2345	One drop

Primary Outcome Measures

Name	Time	Method
Mean Intra Ocular Pressure (IOP) at 8.00am	Day 42 and Day 84 (8.00am for the IOP)	Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 \>= 22 and \<=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.