GlaucomaPhase 1/2NCT05389267
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
A Phase 1/2 study testing Kinezodianone R hydrochloride in people with Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 1 site in United States.
Trial summary
The study purpose is to evaluate the safety of T4090. 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?
- Kinezodianone R hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 6 months
- Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
The study purpose is to evaluate the safety of T4090.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Kinezodianone R hydrochloride, Placebo
- 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.
Kinezodianone R hydrochlorideDrug
Eyedrops
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| T4090 | Experimental | Not described Receives: Drug: Kinezodianone R hydrochloride |
| Placebo | Placebo comparator | named "Vehicle" in the study protocol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular and systemic adverse events
Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.
Measured: up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start5 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389267
- Sponsor's protocol ID
- LT4090-101
- Status last verified
- Feb 2024
- First submitted
- 18 May 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
- ClinicalTrials.gov ID
- NCT05389267
- Acronym / sponsor ID
- LT4090-101
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 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 study purpose is to evaluate the safety of T4090.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T4090 | Experimental | Drug: Kinezodianone R hydrochloride |
| Placebo | Placebo comparator | Drug: Placebonamed "Vehicle" in the study protocol. |
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 6 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 |
|---|---|---|
| Kinezodianone R hydrochlorideEyedrops | Drug | T4090 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Ocular and systemic adverse events
Time frame: up to 22 days
Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Kinezodianone R hydrochloride in people with Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 1 site in United States.
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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Ocular and systemic adverse events (time frame: up to 22 days). 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 7 Feb 2024.