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NCT05729594 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05729594
Other study ID # LT4032-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 27, 2023
Est. completion date April 5, 2023

Study information
Verified date February 2023
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 5, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost Ophthalmic
eyedrops

Locations
Country Name City State
United States Biotrial Newark New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL) at 2 timepoint : Baseline and week 2
Primary Ocular and systemic adverse events up to week 2
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