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OpenTrials
Completed

NCT Number: NCT05729594

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial

Newark, New Jersey, 07103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimatoprost Ophthalmic

Drug

eyedrops

Primary outcomes

  1. Plasma concentrations of bimatoprost and bimatoprost free acid at each timepoint (in ng/mL)

    Time frame: at 2 timepoint : Baseline and week 2

  2. Ocular and systemic adverse events

    Time frame: up to week 2

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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