This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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.
Information provided by (Responsible Party):
Laboratoires Thea Identifier:
First received: December 8, 2011
Last updated: December 22, 2014
Last verified: December 2014
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.


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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Laboratoires Thea Identifier: NCT01494753     History of Changes
Other Study ID Numbers: LT2345-PII-10/07(IN)
Study First Received: December 8, 2011
Results First Received: November 12, 2014
Last Updated: December 22, 2014

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases processed this record on August 23, 2017