Status:
COMPLETED
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Lead Sponsor:
Laboratoires Thea
Conditions:
Ocular Hypertension Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.
Detailed Description
Efficacy Parameters IOP assessment in each eye
Eligibility Criteria
Inclusion
- 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
- History of narrow angle and/or angle closure glaucoma
- Advanced stage of glaucoma
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT04898387
Start Date
March 26 2021
End Date
May 30 2023
Last Update
July 21 2023
Active Locations (1)
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1
Medical Center Vereya EOOD
Stara Zagora, Bulgaria