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Clinical trial

LT2345-PII-10/07(IN)

ID
Name
LT2345-PII-10/07(IN)
Description
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
Trial arms
Trial start
2008-06-01
Estimated PCD
2008-12-01
Trial end
2008-12-01
Status
Completed
Phase
Early phase I
Treatment
T2345
One drop at 8.00pm.
Arms:
T2345
Prostaglandin
One drop at 8.00pm.
Arms:
Prostaglandin
Size
30
Primary endpoint
Mean Intra Ocular Pressure (IOP) at 8.00am
Day 42 and Day 84 (8.00am for the IOP)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-02-07

1 organization

2 products

1 indication

Product
T2345
Indication
Primary Open Angle Glaucoma
Product
Prostaglandin
Organization
Laboratoires Thea