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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01156012
First received: June 30, 2010
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Glaucoma
Drug: T2345
Drug: Prostaglandin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Change in intraocular pressure (IOP) [ Time Frame: Day 84 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in IOP [ Time Frame: Day 15, Day 42 ] [ Designated as safety issue: Yes ]

Enrollment: 463
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T2345
One drop of T2345
Drug: T2345
One drop of T2345
Active Comparator: Prostaglandin
One drop
Drug: Prostaglandin
One drop

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients diagnosed with glaucoma

Exclusion Criteria:

  • Under 18.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156012

Locations
France
Medical Director
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea
  More Information

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01156012     History of Changes
Other Study ID Numbers: LT2345-PIII-12/08, 2009-011157-41
Study First Received: June 30, 2010
Last Updated: December 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 14, 2014