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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05729594

Run by

Laboratoires Thea

People needed

40

Starts

2023-02-27

Expected to finish

2023-04-05

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Biotrial — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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