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

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. Identifier: NCT01494753
Recruitment Status : Completed
First Posted : December 19, 2011
Results First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Information provided by (Responsible Party):
Laboratoires Thea

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

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Drug: T2345 Drug: Prostaglandin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Prostaglandin
One drop.
Drug: Prostaglandin
One drop at 8.00pm.
Experimental: T2345
One drop
Drug: T2345
One drop at 8.00pm.

Primary Outcome Measures :
  1. Mean Intra Ocular Pressure (IOP) at 8.00am [ Time Frame: Day 42 and Day 84 (8.00am for the IOP) ]
    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.

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

Inclusion Criteria:

  • Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria:

  • Any ocular hypertension other than chronic open angle glaucoma

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Laboratoires Thea Identifier: NCT01494753     History of Changes
Other Study ID Numbers: LT2345-PII-10/07(IN)
First Posted: December 19, 2011    Key Record Dates
Results First Posted: January 6, 2015
Last Update Posted: January 6, 2015
Last Verified: December 2014

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases