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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
History of Changes
  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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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
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 May 23, 2013