NCT04898387

Brief Summary

To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
554

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2021

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

March 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

May 4, 2021

Last Update Submit

July 20, 2023

Conditions

Ocular Hypertension Glaucoma

Outcome Measures

Primary Outcomes (1)

  • IOP assessment

    The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP

    Week 12

Secondary Outcomes (1)

  • Ocular Sign

    Week 6 Week 12

Study Arms (2)

T4030 Group

EXPERIMENTAL
Combination Product: Bimatoprost Timolol (T4030)

Ganfort Group

ACTIVE COMPARATOR
Combination Product: Bimatoprost Timolol (Ganfort)

Interventions

Bimatoprost Timolol (T4030)COMBINATION_PRODUCT

Eye drop

Also known as: Bimatoprost Timolol
T4030 Group
Bimatoprost Timolol (Ganfort)COMBINATION_PRODUCT

Eye drop

Also known as: Bimatoprost Timolol
Ganfort Group

Eligibility Criteria

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

You may qualify if:

  • Informed consent signed and dated\*
  • Patient aged ≥18 years old
  • Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
  • Both eyes with diagnosed ocular hypertension or open angle glaucoma

You may not qualify if:

  • History of narrow angle and/or angle closure glaucoma
  • Advanced stage of glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Vereya EOOD

Stara Zagora, Bulgaria

Location

MeSH Terms

Interventions

Ganfort

Study Officials

  • CORENTIN LECAMUS

    Laboratoires Thea

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The 2 different treatment kits should be identical in external packaging in order to respect the masked evaluation for efficacy and safety. The identity of the IMP given to each patient will not be known by the masked investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 24, 2021

Study Start

March 26, 2021

Primary Completion

April 13, 2023

Study Completion

May 30, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)