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

Thea Pharma

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Kinezodianone R hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05389267

LT4090-101

Details and patient eligibility

About

The study purpose is to evaluate the safety of T4090.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

T4090

Experimental group

Treatment:

Drug: Kinezodianone R hydrochloride

Placebo

Placebo Comparator group

Description:

named "Vehicle" in the study protocol.

Treatment:

Drug: Placebo