NCT03825380

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
485

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2018

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

Study Start

First participant enrolled

November 23, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

January 21, 2019

Results QC Date

May 12, 2022

Last Update Submit

February 9, 2023

Conditions

Ocular HypertensionGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Intra-Ocular Pressure

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

    Week 12

Study Arms (2)

T4032

EXPERIMENTAL
Drug: Bimatoprost

Lumigan®

ACTIVE COMPARATOR
Drug: Lumigan®

Interventions

BimatoprostDRUG

Eyedrops

T4032
Lumigan®DRUG

Eyedrops

Lumigan®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital

Tallinn, Estonia

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Corentin LE CAMUS
Organization
Laboratoires Théa
Corentin.LECAMUS@theapharma.com
0473981414

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 31, 2019

Study Start

November 23, 2018

Primary Completion

February 3, 2021

Study Completion

February 24, 2021

Last Updated

November 21, 2023

Results First Posted

November 21, 2023

Record last verified: 2023-02

Locations

ES(1)