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

Last updated: July 20, 2023
Sponsor: Laboratoires Thea
Overall Status: Completed

Phase

3

Condition

Ocular Hypertension

Glaucoma

Treatment

Bimatoprost Timolol (T4030)

Bimatoprost Timolol (Ganfort)

Clinical Study ID

NCT04898387
LT4030-301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 554
Treatment Group(s): 2
Primary Treatment: Bimatoprost Timolol (T4030)
Phase: 3
Study Start date:
March 26, 2021
Estimated Completion Date:
May 30, 2023

Study Description

Efficacy Parameters IOP assessment in each eye

Connect with a study center

  • Medical Center Vereya EOOD

    Stara Zagora,
    Bulgaria

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.