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

July 20, 2023 updated by: Laboratoires Thea
To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Efficacy Parameters IOP assessment in each eye

Study Type

Interventional

Enrollment (Actual)

554

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Stara Zagora, Bulgaria
        • Medical Center Vereya EOOD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T4030 Group
Combination product: Bimatoprost Timolol (T4030)
Eye drop
Other Names:
  • Bimatoprost Timolol
Active Comparator: Ganfort Group
Combination product: Bimatoprost Timolol (Ganfort)
Eye drop
Other Names:
  • Bimatoprost Timolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP assessment
Time Frame: Week 12
The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Sign
Time Frame: Week 6 Week 12
Ocular sign will be assessed through slit lamp examination at each visits
Week 6 Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

  • Study Director: CORENTIN LECAMUS, Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

April 13, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT4030-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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