Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05397600

Enrollment

684

Registered

2022-05-31

Start date

2022-06-22

Completion date

2024-03-07

Last updated

2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Brief summary

The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.

Interventions

DRUGBimatoprost Ophthalmic

Eyedrops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Informed consent dated and signed. * Both eyes diagnosed open-angle glaucoma or ocular hypertension

Exclusion criteria

* History of trauma, infection, clinically significant inflammation within the previous 3 months * Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) * Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.	up to Week12	Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.

Countries

Canada, Colombia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026