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Clinical trial

Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers

ID
Name
LT4032-101
Description
This study is being performed to compare the systemic pharmacokinetic profiles of T4032 and Lumigan 0.01% given that T4032 has a different formulation (in terms of excipients) from the reference product.
Trial arms
Trial start
2023-02-27
Estimated PCD
2023-04-05
Trial end
2023-04-05
Status
Completed
Phase
Early phase I
Treatment
Bimatoprost Ophthalmic
eyedrops
Arms:
Lumigan, T4032
Size
40
Primary endpoint
Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL)
at 2 timepoint : Baseline and week 2
Ocular and systemic adverse events
up to week 2
Eligibility criteria
Inclusion Criteria: * Informed consent signed and dated * Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study * Participants with no ocular symptoms Exclusion Criteria: * History of ocular trauma, infection, or inflammation within the last 3 months * Presence of an ocular pathology such as blepharitis, conjunctivitis, uveitis, or any other ocular infection or inflammation * IOP \<10 mmHg or \>21 mmHg
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-11-14

1 organization

1 product

1 indication

Organization
Laboratoires Thea
Product
Bimatoprost
Indication
Healthy Control Participants