We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01494753
First Posted: December 19, 2011
Last Update Posted: January 6, 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 pharmacokinetics, efficacy and safety of T2345 versus an active comparator.

Condition Intervention Phase
Primary Open Angle Glaucoma Drug: T2345 Drug: Prostaglandin Phase 2

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

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prostaglandin
One drop.
Drug: Prostaglandin
One drop at 8.00pm.
Experimental: T2345
One drop
Drug: T2345
One drop at 8.00pm.

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

Inclusion Criteria:

  • Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria:

  • Any ocular hypertension other than chronic open angle glaucoma
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01494753     History of Changes
Other Study ID Numbers: LT2345-PII-10/07(IN)
First Submitted: December 8, 2011
First Posted: December 19, 2011
Results First Submitted: November 12, 2014
Results First Posted: January 6, 2015
Last Update Posted: January 6, 2015
Last Verified: December 2014

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