NCT05389267

Brief Summary

The study purpose is to evaluate the safety of T4090.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

May 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

May 18, 2022

Last Update Submit

February 6, 2024

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

T4090

EXPERIMENTAL
Drug: Kinezodianone R hydrochloride

Placebo

PLACEBO COMPARATOR

named "Vehicle" in the study protocol.

Drug: Placebo

Interventions

Kinezodianone R hydrochlorideDRUG

Eyedrops

T4090
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr EL-HARAZI

Glendale, California, 91204, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 25, 2022

Study Start

July 5, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

US(1)