NCT05729594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
Last Updated

November 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

January 25, 2023

Last Update Submit

November 10, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

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

    at 2 timepoint : Baseline and week 2

  • Ocular and systemic adverse events

    up to week 2

Study Arms (2)

T4032

EXPERIMENTAL
Drug: Bimatoprost Ophthalmic

Lumigan

ACTIVE COMPARATOR
Drug: Bimatoprost Ophthalmic

Interventions

Bimatoprost OphthalmicDRUG

eyedrops

LumiganT4032

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent signed and dated
  • Participants with no ocular symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotrial

Newark, New Jersey, 07103, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 15, 2023

Study Start

February 27, 2023

Primary Completion

April 5, 2023

Study Completion

April 5, 2023

Last Updated

November 14, 2023

Record last verified: 2023-02

Locations

US(1)