Efficacy and Safety Assessment of T4030 Eye Drops Versus... | NCT04898387

Studies
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.

NCT04898387

Sponsor

Laboratoires Thea

Status

Completed

Last Update Posted

Jul 21, 2023Actual

Enrollment

554Actual

Phase

Phase 3

Conditions

Ocular Hypertension Glaucoma

Interventions

Bimatoprost Timolol (T4030)
Bimatoprost Timolol (Ganfort)

Countries

Bulgaria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2021Actual

Primary Completion Date

Apr 13, 2023Actual

Completion Date

May 30, 2023Actual

First Submitted Date

May 4, 2021

First Submission Date that Met QC Criteria

May 18, 2021

First Posted Date

May 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2023

Last Update Posted Date

Jul 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Efficacy Parameters IOP assessment in each eye

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

554Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T4030 Group	Experimental		Combination Product: Bimatoprost Timolol (T4030)
Ganfort Group	Active Comparator		Combination Product: Bimatoprost Timolol (Ganfort)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bimatoprost Timolol (T4030)	Combination Product	Eye drop	T4030 Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP assessment	The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Ocular Sign	Ocular sign will be assessed through slit lamp examination at each visits	Week 6 Week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CORENTIN LECAMUS	Laboratoires Thea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center Vereya EOOD		Stara Zagora			Bulgaria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571755	Ganfort

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

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

Who Masked

Investigator