Back to resultsPharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
Primary Purpose
Primary Open Angle Glaucoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
T2345
Prostaglandin
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Untreated bilateral newly diagnosed patients with primary open angle glaucoma
Exclusion Criteria:
- Any ocular hypertension other than chronic open angle glaucoma
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Prostaglandin
T2345
Arm Description
One drop.
One drop
Outcomes
Primary Outcome Measures
Mean Intra Ocular Pressure (IOP) at 8.00am
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01494753
Brief Title
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (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 pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostaglandin
Arm Type
Active Comparator
Arm Description
One drop.
Arm Title
T2345
Arm Type
Experimental
Arm Description
One drop
Intervention Type
Drug
Intervention Name(s)
T2345
Intervention Description
One drop at 8.00pm.
Intervention Type
Drug
Intervention Name(s)
Prostaglandin
Intervention Description
One drop at 8.00pm.
Primary Outcome Measure Information:
Title
Mean Intra Ocular Pressure (IOP) at 8.00am
Description
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.
Time Frame
Day 42 and Day 84 (8.00am for the IOP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Untreated bilateral newly diagnosed patients with primary open angle glaucoma
Exclusion Criteria:
Any ocular hypertension other than chronic open angle glaucoma
12. IPD Sharing Statement
Citations:
PubMed Identifier
27310103
Citation
Aptel F, Choudhry R, Stalmans I. Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension. Curr Med Res Opin. 2016 Aug;32(8):1457-63. doi: 10.1080/03007995.2016.1202818. Epub 2016 Jun 25.
Results Reference
derived
Learn more about this trial
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
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