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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Bimatoprost Ophthalmic

• Registration Number: NCT05729594
• Lead Sponsor: Laboratoires Thea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Study Start: 2023-02-27
• Primary Completion: 2023-04-05
• Study Completion: 2023-04-05
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumigan	Bimatoprost Ophthalmic	-
T4032	Bimatoprost Ophthalmic	-

Primary Outcome Measures

Name	Time	Method
Ocular and systemic adverse events	up to week 2
Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL)	at 2 timepoint : Baseline and week 2

Trial Locations

Locations (1)

Biotrial; 🇺🇸 Newark, New Jersey, United States