Back to resultsEfficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
T2345
Prostaglandin
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Adult patients diagnosed with glaucoma
Exclusion Criteria:
- Under 18.
Sites / Locations
- Medical Director
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T2345
Prostaglandin
Arm Description
One drop of T2345
One drop
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156012
Brief Title
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
404 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2345
Arm Type
Experimental
Arm Description
One drop of T2345
Arm Title
Prostaglandin
Arm Type
Active Comparator
Arm Description
One drop
Intervention Type
Drug
Intervention Name(s)
T2345
Intervention Description
One drop of T2345
Intervention Type
Drug
Intervention Name(s)
Prostaglandin
Intervention Description
One drop
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP)
Description
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.
Time Frame
Day 0 and Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients diagnosed with glaucoma
Exclusion Criteria:
Under 18.
Facility Information:
Facility Name
Medical Director
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
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