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

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ClinicalTrials.gov Identifier: NCT01156012
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : November 19, 2014
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Brief Summary:
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: T2345 Drug: Prostaglandin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: T2345
One drop of T2345
Drug: T2345
One drop of T2345
Active Comparator: Prostaglandin
One drop
Drug: Prostaglandin
One drop



Primary Outcome Measures :
  1. 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.




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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.

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

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 Posted: July 2, 2010    Key Record Dates
Results First Posted: November 19, 2014
Last Update Posted: January 22, 2015
Last Verified: December 2014