Safety Assessment of T4090 Eye Drops in Ocular Hypertensi... | NCT05389267

Studies
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.

NCT05389267

Sponsor

Laboratoires Thea

Status

Active, not recruiting

Last Update Posted

Feb 7, 2024Actual

Enrollment

120Estimated

Phase

Phase 1Phase 2

Conditions

Glaucoma
Ocular Hypertension

Interventions

Kinezodianone R hydrochloride
Placebo

Countries

United States

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

May 18, 2022

First Submission Date that Met QC Criteria

May 24, 2022

First Posted Date

May 25, 2022Actual

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

Feb 6, 2024

Last Update Posted Date

Feb 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

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

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T4090	Experimental		Drug: Kinezodianone R hydrochloride
Placebo	Placebo Comparator	named "Vehicle" in the study protocol.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kinezodianone R hydrochloride	Drug	Eyedrops	T4090
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular and systemic adverse events	Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.	up to 22 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 6 months
Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
Pregnancy or breast-feeding

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr EL-HARAZI		Glendale	California	91204	United States

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 27, 2024			Jan 21, 2025	3

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided