GlaucomaPhase 3NCT05397600
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
A Phase 3 study testing Bimatoprost Ophthalmic in people with Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 64 sites in 3 countries.
Trial summary
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Bimatoprost Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 64 sitesin 3 countries
- Study dates
- 22 Jun 2022to 7 Mar 2024
- 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 dated and signed.
- Both eyes diagnosed open-angle glaucoma or ocular hypertension
Who cannot join
- History of trauma, infection, clinically significant inflammation within the previous 3 months
- Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- Pregnancy or breast-feeding
Trial locations and contacts
64 sites in 3 countries.
64 sites in 3 countries
United States56 sites
Texan Eye - Austin - Main Central
Austin, Texas, 78731-4203
Specialty Eye Care Center - Bellevue
Bellevue, Washington, 98004-3019
Velvet Clinical Research
Burbank, California, 91506-1773
Arizona Eye Center - Chandler
Chandler, Arizona, 85224-0002
Cincinnati Eye Institute - Blue Ash
Cincinnati, Ohio, 45242-5664
Abrams Eye Center, Inc.
Cleveland, Ohio, 44115-3100
Scott & White Cancer Center - Killeen
Cranberry Township, Pennsylvania, 16066-6412
Nature Coast Clinical Research - Crystal River
Crystal River, Florida, 34429-8722
Southwest Eye Institute
El Paso, Texas, 79902
Fraser Eye Care Center - Fraser
Fraser, Michigan, 48026-2038
Eye Physicians & Surgeons of Arizona - Glendale Office
Glendale, Arizona, 85306
Specialty Eye Care Medical Center - Glendale
Glendale, California, 91203-2001
Global Research Management, Inc.
Glendale, California, 91204-2500
Advancing Vision Research - Goodlettsville
Goodlettsville, Tennessee, 37072
ICON Eye Care - Grand Junction
Grand Junction, Colorado, 81501
Inland Eye Specialists - Hemet
Hemet, California, 92545-9687
NV Eye Surgery - Henderson
Henderson, Nevada, 89052-5084
Houston Eye Associates - North Loop
Houston, Texas, 77022-5332
Houston Eye Associates (HEA) - Gramercy Location
Houston, Texas, 77025-1756
Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, 46202-5209
Diabetic Eye Medical Clinic - Inglewood
Inglewood, California, 90301-1413
Lakeside Vision Center - Irvine
Irvine, California, 92604-1726
East Coast Institute for Research - Jacksonville
Jacksonville, Florida, 32256
Sage Eyecare
Los Angeles, California, 90017
Global Vision Eye Care - Los Angeles- Rock Central
Los Angeles, California, 90041-1718
Piedmont Eye Center - Lynchburg
Lynchburg, Virginia, 24502-4271
AMA Eye Research Institute
Marysville, Ohio, 43040
Total Eye Care, P.A.
Memphis, Tennessee, 38119-5770
North Valley Eye Medical Group, Inc.
Mission Hills, California, 91345-1246
California Eye Specialists Medical Group Inc. - Monrovia
Monrovia, California, 91016-1938
Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus
Nashville, Tennessee, 37232-0025
Aesthetic Eye Care Institute - Eye Research Foundation
Newport Beach, California, 92663-3642
Ocala Eye - 3130 Location
Ocala, Florida, 34474-4445
Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens
Palm Beach Gardens, Florida, 33418-3701
Foothill Eye Institute - Pasadena
Pasadena, California, 91107-3747
North Bay Eye Associates - Petaluma - 104 Lynch Creek Way
Petaluma, California, 94954-2355
Scheie Eye Institute - University of Pennsylvania
Philadelphia, Pennsylvania, 19104-2640
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107-5109
Arizona Glaucoma Specialists - Phoenix
Phoenix, Arizona, 85050
Legacy Pulmonary Medical Group - Good Samaritan Medical Center
Portland, Oregon, 97210-3049
California Eye Specialists Medical Group Inc. - Redlands
Redlands, California, 92373-3125
Rochester Ophthalmological Group, PC - Brighton
Rochester, New York, 14618-2616
Coastal Research Associates, LLC. - Atlanta
Roswell, Georgia, 30076-5610
Coastal Research Associates, LLC. - Atlanta
Roswell, Georgia, 30076-5650
Great Lakes Eye Care - St. Joseph
Saint Joseph, Michigan, 49085-3352
San Antonio Eye Center, P.A. - McCullough Ave
San Antonio, Texas, 78215-1625
Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic
San Antonio, Texas, 78229-3539
OC Surgical Eye Institute
Santa Ana, California, 92705-4079
Santa Barbara Eyecare - Santa Barbara
Santa Barbara, California, 93105-3310
St. George Eye Center - St. George
St. George, Utah, 84790-8720
East Florida Eye Institute
Stuart, Florida, 34994-2579
Walman Eye Center - Sun City
Sun City, Arizona, 85351-3019
Wolstan & Goldberg Eye Associates
Torrance, California, 90505-4036
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090-3010
"Clinic-LJ" Ltd
Winston-Salem, North Carolina, 27101-3911
Huron Ophthalmology, P.C.
Ypsilanti, Michigan, 48197-1102
Colombia6 sites
Clínica Oftalmológica del Caribe
Barranquilla, 80001
Fundación Oftalmológica Nacional (FUNDONAL)
Bogotá, 110231
Clinica de Oftalmologia de Cali SA
Cali, 760001
Fundación Oftalmológica de Santander FOSCAL
Floridablanca, 681004
Clinica de Oftalmologia Sandiego
Medellín, 050016
Instituto Nacional de Investigacion en Oftalmologia
Medellín, 050021
Canada2 sites
Clinique Bellevue - Laval
Laval, Quebec, H7N 4B2
Prism Eye Institute - Oakville
Oakville, Ontario, L6H 0J8
About this study
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Bimatoprost Ophthalmic
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost OphthalmicDrug
Eyedrops
| Study group | Role | What they receive |
|---|---|---|
| T4032 | Experimental | Not described Receives: Drug: Bimatoprost Ophthalmic |
| Lumigan | Active comparator | Not described Receives: Drug: Bimatoprost Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.
Measured: up to Week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start22 Jun 2022
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 684 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
- NCT05397600
- Sponsor's protocol ID
- LT4032-302
- Status last verified
- Nov 2023
- First submitted
- 25 May 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
- ClinicalTrials.gov ID
- NCT05397600
- Acronym / sponsor ID
- LT4032-302
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 31 May 2022 (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.
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
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 Ophthalmic |
| Lumigan | Active comparator | Drug: Bimatoprost Ophthalmic |
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 dated and signed.
- Both eyes diagnosed open-angle glaucoma or ocular hypertension
Key exclusion criteria (3 listed)
- History of trauma, infection, clinically significant inflammation within the previous 3 months
- Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- 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 |
|---|---|---|
| Bimatoprost OphthalmicEyedrops | Drug | Lumigan, T4032 |
Primary outcome
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
Time frame: up to Week12
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.
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 18 Jul 2024.
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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.
64 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimatoprost Ophthalmic in people with Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 64 sites in 3 countries.
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 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Colombia, Canada. 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?
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP. (time frame: up to Week12). 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 18 Jul 2024.