Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Laboratoires Thea
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01494753
First received: December 8, 2011
Last updated: December 15, 2011
Last verified: December 2011
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Purpose
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Open Angle Glaucoma |
Drug: T2345 Drug: Prostaglandin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Laboratoires Thea:
Primary Outcome Measures:
- Mean diurnal IOP at Day 42 [ Time Frame: Day 42 (8.00am for the IOP) ] [ Designated as safety issue: Yes ]- Efficacy criteria (Mean diurnal IOP) at 8:00am on Day 42.
| Enrollment: | 30 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Prostaglandin
One drop.
|
Drug: Prostaglandin
One drop at 8.00pm.
|
|
Experimental: T2345
One drop
|
Drug: T2345
One drop at 8.00pm.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Untreated bilateral newly diagnosed patients with primary open angle glaucoma
Exclusion Criteria:
- Any ocular hypertension other than chronic open angle glaucoma
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Laboratoires Thea |
| ClinicalTrials.gov Identifier: | NCT01494753 History of Changes |
| Other Study ID Numbers: | LT2345-PII-10/07(IN) |
| Study First Received: | December 8, 2011 |
| Last Updated: | December 15, 2011 |
| Health Authority: | India: Ministry of Health |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013