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Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03825380
Enrollment
485
Registered
2019-01-31
Start date
2018-11-23
Completion date
2021-02-24
Last updated
2023-11-21

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 purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.

Interventions

DRUGBimatoprost

Eyedrops

DRUGLumigan®

Eyedrops

Sponsors

Laboratoires Thea
Lead SponsorINDUSTRY

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
No

Inclusion criteria

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

Exclusion criteria

* History of trauma, infection, clinically significant inflammation within the 3 previous months. * Uncontrolled diabetic patient. * Pregnancy or breast feeding.

Design outcomes

Primary

MeasureTime frameDescription
Intra-Ocular PressureWeek 12Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye

Countries

Estonia

Participant flow

Recruitment details

485 patients (from 723 screened patients) were included and randomised in the study: 485 patients in the intent-to-treat (ITT) set and Safety set, 469 in the modified ITT (mITT) set. The recruitment started on 23-NOV-2018 and was completed on 28-AUG-2020 and the last patient completed the study on 24-FEB-2021.

Pre-assignment details

Incl/Excl criteria checked at screening visit, then patients discontinued their current treatment to start the run-in period with Azopt, for 5 weeks. The Azopt was stopped 1 or 2 weeks before the randomisation visit (Day 1). Incl/Excl criteria are confirmed at Day 1. 723 screened patients, 485 randomised patients, 238 screen failure patients.

Participants by arm

ArmCount
T4032
Bimatoprost: Eyedrops
236
Lumigan®
Lumigan®: Eyedrops
249
Total485

Baseline characteristics

CharacteristicT4032TotalLumigan®
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
110 Participants234 Participants124 Participants
Age, Categorical
Between 18 and 65 years
126 Participants251 Participants125 Participants
Age, Continuous63.03 years
STANDARD_DEVIATION 11.85
63.36 years
STANDARD_DEVIATION 11.38
63.67 years
STANDARD_DEVIATION 10.92
Race and Ethnicity Not Collected—0 Participants—
Region of Enrollment
Belgium
5 participants8 participants3 participants
Region of Enrollment
Bulgaria
41 participants80 participants39 participants
Region of Enrollment
Canada
4 participants7 participants3 participants
Region of Enrollment
Czechia
21 participants40 participants19 participants
Region of Enrollment
Estonia
6 participants14 participants8 participants
Region of Enrollment
France
10 participants23 participants13 participants
Region of Enrollment
Georgia
5 participants12 participants7 participants
Region of Enrollment
Germany
4 participants8 participants4 participants
Region of Enrollment
Greece
4 participants13 participants9 participants
Region of Enrollment
Hungary
2 participants2 participants0 participants
Region of Enrollment
Italy
13 participants25 participants12 participants
Region of Enrollment
Latvia
9 participants20 participants11 participants
Region of Enrollment
Lithuania
4 participants7 participants3 participants
Region of Enrollment
Mauritius
1 participants1 participants0 participants
Region of Enrollment
Poland
20 participants47 participants27 participants
Region of Enrollment
Russia
30 participants61 participants31 participants
Region of Enrollment
Slovakia
10 participants22 participants12 participants
Region of Enrollment
Spain
14 participants28 participants14 participants
Region of Enrollment
Tunisia
17 participants36 participants19 participants
Region of Enrollment
Ukraine
16 participants30 participants14 participants
Region of Enrollment
United Kingdom
0 participants1 participants1 participants
Sex: Female, Male
Female
141 Participants294 Participants153 Participants
Sex: Female, Male
Male
95 Participants191 Participants96 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2360 / 249
other
Total, other adverse events
13 / 23617 / 249
serious
Total, serious adverse events
1 / 2362 / 249

Outcome results

Primary

Intra-Ocular Pressure

Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye

Time frame: Week 12

Population: Modified Intent To Treat

ArmMeasureValue (MEAN)Dispersion
T4032Intra-Ocular Pressure-9.67 mmHgStandard Error 0.19
Lumigan®Intra-Ocular Pressure-9.50 mmHgStandard Error 0.18
p-value: 0.45395% CI: [-0.62, 0.28]Mixed Models Analysis

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