Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

Thea Pharma

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Lumigan®; Drug: Bimatoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT03825380

LT4032-301

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.

Enrollment: 485 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• History of trauma, infection, clinically significant inflammation within the 3 previous months.
• Uncontrolled diabetic patient.
• Pregnancy or breast feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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485 participants in 2 patient groups

T4032

Experimental group

Treatment:

Drug: Bimatoprost

Lumigan®

Active Comparator group

Treatment:

Drug: Lumigan®