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

Phase 2CompletedNCT01494753

Laboratoires Thea30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Open Angle Glaucoma

Interventions

T2345DRUG

One drop at 8.00pm.

ProstaglandinDRUG

One drop at 8.00pm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Untreated bilateral newly diagnosed patients with primary open angle glaucoma Exclusion Criteria: * Any ocular hypertension other than chronic open angle glaucoma

Outcomes

Primary Outcomes

Mean Intra Ocular Pressure (IOP) at 8.00am

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.

Time frame: Day 42 and Day 84 (8.00am for the IOP)

Data from ClinicalTrials.gov

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