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NCT05729594
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 40
Sponsor: Laboratoires Thea
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Informed consent signed and datedHealthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the studyParticipants with no ocular symptomsExclusion Criteria:History of ocular trauma, infection, or inflammation within the last 3 monthsPresence of an ocular pathology such as blepharitis, conjunctivitis, uveitis, or any other ocular infection or inflammationIOP <10 mmHg or >21 mmHg
Source: ClinicalTrials.gov (NCT05729594). StuddyBuddy aggregates publicly available trial information.