Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 19, 2011
CompletedResults Posted
Study results publicly available
January 6, 2015
CompletedFebruary 7, 2024
February 1, 2024
6 months
December 8, 2011
November 12, 2014
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Day 42 and Day 84 (8.00am for the IOP)
Study Arms (2)
Prostaglandin
ACTIVE COMPARATOROne drop.
T2345
EXPERIMENTALOne drop
Interventions
Eligibility Criteria
You may qualify if:
- Untreated bilateral newly diagnosed patients with primary open angle glaucoma
You may not qualify if:
- Any ocular hypertension other than chronic open angle glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27310103DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Pascale Pouliquen - Medical Director
- Organization
- Laboratoires Théa
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 19, 2011
Study Start
June 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
February 7, 2024
Results First Posted
January 6, 2015
Record last verified: 2024-02