Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.

Thea Pharma

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension Glaucoma

Treatments: Combination Product: Bimatoprost Timolol (Ganfort); Combination Product: Bimatoprost Timolol (T4030)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04898387

LT4030-301

Details and patient eligibility

About

To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.

Full description

Efficacy Parameters IOP assessment in each eye

Enrollment: 554 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent signed and dated*
• Patient aged ≥18 years old
• Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
• Both eyes with diagnosed ocular hypertension or open angle glaucoma

Exclusion criteria

• History of narrow angle and/or angle closure glaucoma
• Advanced stage of glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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554 participants in 2 patient groups

T4030 Group

Experimental group

Treatment:

Combination Product: Bimatoprost Timolol (T4030)

Ganfort Group

Active Comparator group

Treatment:

Combination Product: Bimatoprost Timolol (Ganfort)