Clinical trial
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
Name
LT4090-101
Description
The study purpose is to evaluate the safety of T4090.
Trial arms
Trial start
2022-07-05
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Kinezodianone R hydrochloride
Eyedrops
Arms:
T4090
Placebo
Placebo
Arms:
Placebo
Size
120
Primary endpoint
Ocular and systemic adverse events
up to 22 days
Eligibility criteria
Inclusion Criteria:
* Informed consent dated and signed.
* Both eyes diagnosed open-angle glaucoma or ocular hypertension
Exclusion Criteria:
* History of trauma, infection, clinically significant inflammation within the previous 6 months
* Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
* Pregnancy or breast-feeding
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-02-07
1 organization
2 products
2 indications
Organization
Laboratoires TheaProduct
PlaceboIndication
GlaucomaIndication
ocular hypertensionProduct
Kinezodianone R