Skip to main content
OpenTrials
Completed

NCT Number: NCT04898387

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ocular Hypertension Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Center Vereya EOOD

Stara Zagora, Bulgaria

About this study

Efficacy Parameters IOP assessment in each eye

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimatoprost Timolol (T4030)

Combination Product

Eye drop

Other names: Bimatoprost Timolol

Bimatoprost Timolol (Ganfort)

Combination Product

Eye drop

Other names: Bimatoprost Timolol

Primary outcomes

  1. IOP assessment

    Time frame: Week 12

    The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP

Secondary outcomes

  1. Ocular Sign

    Time frame: Week 6 Week 12

    Ocular sign will be assessed through slit lamp examination at each visits

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 24, 2021
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.