GlaucomaPhase 2NCT06394973

Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

A Phase 2 study testing T4090 0.2%, T4090 0.3% and Rhopressa® in people with Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 24 sites in United States.

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

The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution 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?: T4090 0.2%, T4090 0.3% and Rhopressa®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 24 sitesUnited States
Study dates: 5 Aug 2024to 21 Nov 2024
Phase: Phase 2
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

Main Inclusion Criteria:

Patient (male or female) ≥18 years old
Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes
Informed consent dated and signed.

Main Exclusion Criteria:

Secondary Open Agle Glaucoma (ex. Pseudoexfoliation, Pigmentary glaucoma)
Advanced stage of glaucoma
History of ocular trauma, eye infection, or/and ocular clinically significant inflammation within the 6 previous months.
Known or suspected hypersensitivity to one of the components of the IMPs or other product used in the clinical study
Pregnancy (confirmed with a positive urine pregnancy test) or breast-feeding.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Keystone Research
Austin, Texas, 78731
Glaucoma Associates of Texas
Dallas, Texas, 75231
Segal Drug Trials, Inc
Delray Beach, Florida, 33484
Emerson Clinical Research Institute
Falls Church, Virginia, 22046
Arizona Advanced Eye Research Institute
Glendale, Arizona, 85306
Global Research Management, Inc.
Glendale, California, 91204
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Houston Eye Associates
Houston, Texas, 53719
Houston Eye Associates
Houston, Texas, 77008
United Medical Research Institute
Inglewood, California, 90301
East Coast Institute for Research, LLC
Jacksonville, Florida, 32256
Shettle Eye Research, Inc.
Largo, Florida, 33773
Piedmont Eye Center
Lynchburg, Virginia, 24502
Total Eye Care, PA
Memphis, Tennessee, 38119
DCT-Shah Research, LLC sba Discovery Clinical Trials
Mission, Texas, 78572
Mild Florida Eye Center
Mt. Dora, Florida, 32757
Eye Research Foundation
Newport Beach, California, 92663
Visionary Research Institute
Newport Beach, California, 92663
North Bay Eye Associates
Petaluma, California, 94954
Alterman, Modi and Wolter Ophthalmic Surgeons
Poughkeepsie, New York, 12603
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Sacramento Eye Consultants, A Medical Corporation
Sacramento, California, 95815
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
James D. Branch, MD
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: Efficacy and Safety Assessment of T4090 Ophthalmic Solution (Preservative-free Kinezodianone R HCl 0.2% or 0.3%) Versus Rhopressa® Ophthalmic Solution (Preserved Netarsudil 0.02%) in Patients With Open-angle Glaucoma or Ocular Hypertension

The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution

Conditions: Glaucoma, Ocular Hypertension
Being tested: T4090 0.2%, T4090 0.3%, Rhopressa®
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.

T4090 0.2%Drug
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
T4090 0.3%Drug
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).
Rhopressa®Drug
1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).

Study groups in NCT06394973
Study group	Role	What they receive
T4090 0.2%	Experimental	Not described Receives: Drug: T4090 0.2%
T4090 0.3%	Experimental	Not described Receives: Drug: T4090 0.3%
Rhopressa®	Active comparator	Not described Receives: Drug: Rhopressa®

What is being measured

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

Mean Diurnal IOP
IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator.
Mean diurnal is calculated from these three timepoints.
Measured: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.

Timeline

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

5 Aug 202421 Nov 2024

First posted1 May 2024
Study start5 Aug 2024
Primary completion21 Nov 2024
Study completion21 Nov 2024

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06394973
Sponsor's protocol ID: LT4090-201
Status last verified: Dec 2025
First submitted: 29 Apr 2024
Last updated: 2 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Assessment of T4090 Ophthalmic Solution (Preservative-free Kinezodianone R HCl 0.2% or 0.3%) Versus Rhopressa® Ophthalmic Solution (Preserved Netarsudil 0.02%) in Patients With Open-angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT06394973
Acronym / sponsor ID: LT4090-201
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: 5 Aug 2024 (actual)
Primary completion: 21 Nov 2024 (actual)
Study completion: 21 Nov 2024 (actual)
First posted: 1 May 2024 (actual)
Results: Posted 2 Jan 2026

Clinical summary

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

The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
T4090 0.2%	Experimental	Drug: T4090 0.2%
T4090 0.3%	Experimental	Drug: T4090 0.3%
Rhopressa®	Active comparator	Drug: Rhopressa®

Who may qualify

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

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
T4090 0.2%1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).	Drug	T4090 0.2%
T4090 0.3%1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).	Drug	T4090 0.3%
Rhopressa®1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7).	Drug	Rhopressa®

Primary outcome

Mean Diurnal IOP
Time frame: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.
IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator. Mean diurnal is calculated from these three timepoints.

Results and safety

Results posted to the registry on 2 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T4090 0.2%	53	48
T4090 0.3%	53	48
Rhopressa®	53	49

Primary outcome: Mean Diurnal IOP

Time frame: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.. Mean (Standard Deviation). Unit: mmHg

Measure	T4090 0.2% n = 45	T4090 0.3% n = 42	Rhopressa® n = 47
Value	-5.07 (2.75)	-4.73 (2.94)	-4.6 (3.06)

T4090 0.2% vs Rhopressa®: Mean Difference (Final Values): -0.49, p = 0.376, Mixed Models Analysis
T4090 0.3% vs Rhopressa®: Mean Difference (Final Values): -0.36, p = 0.518, Mixed Models Analysis

Population analysed: Primary estimand - Full Set Analysis

Adverse events

Time frame: Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T4090 0.2%	0 of 53 (0%)	46 of 53 (86.8%)	0 of 53
T4090 0.3%	0 of 53 (0%)	46 of 53 (86.8%)	0 of 53
Rhopressa®	1 of 53 (1.9%)	36 of 53 (67.9%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing T4090 0.2%, T4090 0.3% and Rhopressa® in people with Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 24 sites 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?

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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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. 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 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?

Yes. Results are posted in the registry (first posted 2 Jan 2026). 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?

Mean Diurnal IOP (time frame: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.). 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 NCT06394973.

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 2 Jan 2026.