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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156012
• Other study ID #: LT2345-PIII-12/08
• Secondary ID: 2009-011157-41
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2010
• Last updated: January 9, 2015
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult patients diagnosed with glaucoma

Exclusion Criteria:

• Under 18.

Study Design

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• T2345
One drop of T2345
• Prostaglandin
One drop

Locations

Country	Name	City	State
France	Medical Director	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure (IOP)	The worse eye is defined as: If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.; If only one eye is eligible this eye is the worse eye.; If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.; If both eyes have the same IOP at D0 the worse eye is the right eye.	Day 0 and Day 84	No