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

Thea Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Bimatoprost Ophthalmic

Study type: Interventional

Funder types: Industry

Identifiers

NCT05729594

LT4032-101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

T4032

Experimental group

Treatment:

Drug: Bimatoprost Ophthalmic

Lumigan

Active Comparator group

Treatment:

Drug: Bimatoprost Ophthalmic