Ocular HypertensionPhase 3NCT03825380
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
A Phase 3 study testing Bimatoprost and Lumigan® in people with Ocular Hypertension and Glaucoma, run by Laboratoires Thea at 1 site in Estonia.
Trial summary
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan. 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 and Lumigan®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 1 siteEstonia
- Study dates
- 23 Nov 2018to 24 Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Both eyes with diagnosed open-angle glaucoma or ocular hypertension
Who cannot join
- History of trauma, infection, clinically significant inflammation within the 3 previous months.
- Uncontrolled diabetic patient.
- Pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.
- Conditions
- Ocular Hypertension, Glaucoma
- Being tested
- Bimatoprost, Lumigan®
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimatoprostDrug
Eyedrops
Lumigan®Drug
Eyedrops
| Study group | Role | What they receive |
|---|---|---|
| T4032 | Experimental | Not described Receives: Drug: Bimatoprost |
| Lumigan® | Active comparator | Not described Receives: Drug: Lumigan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-Ocular Pressure
Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 Nov 2018
- Primary completion3 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular HypertensionStudies 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
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825380
- Sponsor's protocol ID
- LT4032-301
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2019
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
- ClinicalTrials.gov ID
- NCT03825380
- Acronym / sponsor ID
- LT4032-301
- Conditions
- Ocular Hypertension, Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T4032 | Experimental | Drug: Bimatoprost |
| Lumigan® | Active comparator | Drug: Lumigan® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent signed and dated.
- Both eyes with diagnosed open-angle glaucoma or ocular hypertension
Key exclusion criteria (3 listed)
- History of trauma, infection, clinically significant inflammation within the 3 previous months.
- Uncontrolled diabetic patient.
- Pregnancy or breast feeding.
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 |
|---|---|---|
| BimatoprostEyedrops | Drug | T4032 |
| Lumigan®Eyedrops | Drug | Lumigan® |
Primary outcome
Intra-Ocular Pressure
Time frame: Week 12
Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Lumigan® in people with Ocular Hypertension and Glaucoma, run by Laboratoires Thea at 1 site in Estonia.
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 2 inclusion and 3 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 Nov 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 Estonia. 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?
Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intra-Ocular Pressure (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2023.