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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156012
First Posted: July 2, 2010
Last Update Posted: January 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratoires Thea
  Purpose
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Condition Intervention Phase
Glaucoma Drug: T2345 Drug: Prostaglandin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Adult patients diagnosed with glaucoma

Exclusion Criteria:

  • Under 18.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156012


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

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01156012     History of Changes
Other Study ID Numbers: LT2345-PIII-12/08
2009-011157-41 ( EudraCT Number )
First Submitted: June 30, 2010
First Posted: July 2, 2010
Results First Submitted: November 12, 2014
Results First Posted: November 19, 2014
Last Update Posted: January 22, 2015
Last Verified: December 2014