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

January 9, 2015 updated by: Laboratoires Thea
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Medical Director

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients diagnosed with glaucoma

Exclusion Criteria:

  • Under 18.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: T2345
One drop of T2345
Drug: T2345
One drop of T2345
ACTIVE_COMPARATOR: Prostaglandin
One drop
Drug: Prostaglandin
One drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Intraocular Pressure (IOP)
Time Frame: 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.
Day 0 and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (ESTIMATE)

July 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2345-PIII-12/08
  • 2009-011157-41 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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