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NCT01494753 Clinical Trial

Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension

Primary Open Angle Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01494753
Other study ID # LT2345-PII-10/07(IN)
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2008
Est. completion date December 2008

Study information
Verified date February 2024
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Untreated bilateral newly diagnosed patients with primary open angle glaucoma Exclusion Criteria: - Any ocular hypertension other than chronic open angle glaucoma

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• T2345
One drop at 8.00pm.
• Prostaglandin
One drop at 8.00pm.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
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