Ocular Hypertension GlaucomaPhase 3NCT04898387

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

A Phase 3 study testing Bimatoprost Timolol (T4030) and Bimatoprost Timolol (Ganfort) in people with Ocular Hypertension Glaucoma, run by Laboratoires Thea at 1 site in Bulgaria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Hypertension Glaucoma
What is being tested?: Bimatoprost Timolol (T4030) and Bimatoprost Timolol (Ganfort)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 554 participants
Where: 1 siteBulgaria
Study dates: 26 Mar 2021to 30 May 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Bulgaria1 site

Medical Center Vereya EOOD
Stara Zagora

Other trials in Bulgaria

About this study

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

Read the detailed description

Efficacy Parameters IOP assessment in each eye

Conditions: Ocular Hypertension Glaucoma
Being tested: Bimatoprost Timolol (T4030), Bimatoprost Timolol (Ganfort)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bimatoprost Timolol (T4030)Combination product
Also called Bimatoprost Timolol
Eye drop
Bimatoprost Timolol (Ganfort)Combination product
Also called Bimatoprost Timolol
Eye drop

Study groups in NCT04898387
Study group	Role	What they receive
T4030 Group	Experimental	Not described Receives: Combination Product: Bimatoprost Timolol (T4030)
Ganfort Group	Active comparator	Not described Receives: Combination Product: Bimatoprost Timolol (Ganfort)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Ocular Sign
Ocular sign will be assessed through slit lamp examination at each visits
Measured: Week 6 Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202130 May 2023

First posted24 May 2021
Study start26 Mar 2021
Primary completion13 Apr 2023
Study completion30 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ocular Hypertension GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04898387
Sponsor's protocol ID: LT4030-301
Status last verified: Jul 2023
First submitted: 4 May 2021
Last updated: 21 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
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A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

All Ocular Hypertension Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
ClinicalTrials.gov ID: NCT04898387
Acronym / sponsor ID: LT4030-301
Conditions: Ocular Hypertension Glaucoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 554 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: 26 Mar 2021 (actual)
Primary completion: 13 Apr 2023 (actual)
Study completion: 30 May 2023 (actual)
First posted: 24 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
T4030 Group	Experimental	Combination Product: Bimatoprost Timolol (T4030)
Ganfort Group	Active comparator	Combination Product: Bimatoprost Timolol (Ganfort)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bimatoprost Timolol (T4030)Also: Bimatoprost TimololEye drop	Combination product	T4030 Group
Bimatoprost Timolol (Ganfort)Also: Bimatoprost TimololEye drop	Combination product	Ganfort Group

Primary outcome

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

1 secondary outcome

Ocular Sign
Time frame: Week 6 Week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
Individual participant dataSharing planned: No

Related trials for Ocular Hypertension Glaucoma

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

CORENTIN LECAMUS study director

Laboratoires Thea

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimatoprost Timolol (T4030) and Bimatoprost Timolol (Ganfort) in people with Ocular Hypertension Glaucoma, run by Laboratoires Thea at 1 site in Bulgaria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IOP assessment (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04898387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.