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

NCT ID: NCT05729594

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2023-04-05

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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T4032

Group Type EXPERIMENTAL

Bimatoprost Ophthalmic

Intervention Type DRUG

eyedrops

Lumigan

Group Type ACTIVE_COMPARATOR

Bimatoprost Ophthalmic

Intervention Type DRUG

eyedrops

Interventions

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Bimatoprost Ophthalmic

eyedrops

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biotrial

Newark, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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LT4032-101

Identifier Type: -

Identifier Source: org_study_id

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