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

This study has been completed.
Information provided by (Responsible Party):
Laboratoires Thea Identifier:
First received: June 30, 2010
Last updated: January 9, 2015
Last verified: December 2014
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Condition Intervention Phase
Drug: T2345
Drug: Prostaglandin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • 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.

Enrollment: 404
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T2345
One drop of T2345
Drug: T2345
One drop of T2345
Active Comparator: Prostaglandin
One drop
Drug: Prostaglandin
One drop


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients diagnosed with glaucoma

Exclusion Criteria:

  • Under 18.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01156012

Medical Director
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea
  More Information

Responsible Party: Laboratoires Thea Identifier: NCT01156012     History of Changes
Other Study ID Numbers: LT2345-PIII-12/08
2009-011157-41 ( EudraCT Number )
Study First Received: June 30, 2010
Results First Received: November 12, 2014
Last Updated: January 9, 2015 processed this record on May 24, 2017