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 15, 2011
Last verified: December 2011
  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 diurnal IOP at Day 42 [ Time Frame: Day 42 (8.00am for the IOP) ] [ Designated as safety issue: Yes ]
    - Efficacy criteria (Mean diurnal IOP) at 8:00am on Day 42.


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
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
Last Updated: December 15, 2011
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014