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:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01494753
First received: December 8, 2011
Last updated: December 22, 2014
Last verified: December 2014
  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 Blind (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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov 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
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on May 04, 2015