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NCT05389267 Clinical Trial

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

Glaucoma Clinical Trial

Official title:
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05389267
Other study ID # LT4090-101
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 5, 2022
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study purpose is to evaluate the safety of T4090.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Kinezodianone R hydrochloride
Eyedrops
• Placebo
Placebo

Locations
Country Name City State
United States Dr EL-HARAZI Glendale California

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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