T4090 vs Rhopressa for Glaucoma

Not currently recruiting at 24 trial locations
CL
JH
Overseen ByJames H. Peace
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Laboratoires Thea
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two doses of a new eye drop, T4090, against an existing treatment, Rhopressa®, to determine which is more effective and safer for lowering eye pressure. It targets individuals with open-angle glaucoma or ocular hypertension, conditions that cause high eye pressure. Candidates should have these conditions in both eyes and no recent eye injuries or infections. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important advancements in eye care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that T4090, a new eye drop under study, is being tested in two strengths (0.2% and 0.3%) for treating glaucoma. Since this study is in its early stages, limited information exists about how well people tolerate T4090. However, early studies usually focus on safety, suggesting that initial tests have likely shown some safety.

Rhopressa® is already approved for treating glaucoma, indicating it has undergone thorough testing and is considered safe for patients with this condition.

For those considering joining the trial, it is important to know that researchers are carefully monitoring both treatments for safety and side effects. Always discuss any risks and benefits with a doctor.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about T4090 for glaucoma because it offers a new approach to managing intraocular pressure, which is crucial for glaucoma patients. Unlike the standard treatments that often focus on aqueous humor outflow, T4090 is being tested in two concentrations (0.2% and 0.3%) and has the potential to provide more effective pressure reduction. This treatment could be a game-changer by offering an alternative for patients who might not respond well to existing options like prostaglandin analogs or beta-blockers. If successful, T4090 might offer better control with fewer side effects, enhancing patient outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for glaucoma?

Studies have shown that Rhopressa® effectively lowers eye pressure, crucial for managing glaucoma. One study found that Rhopressa® reduced eye pressure in 58% of cases that would have otherwise required more invasive treatments like laser therapy or surgery. In this trial, participants will receive either Rhopressa® or T4090. Early results suggest that T4090 might also help lower eye pressure. Researchers are comparing two strengths of T4090, 0.2% and 0.3%, to evaluate their effectiveness. While T4090 is still under investigation, there is hope it could become a new option for people with glaucoma.12678

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Open-Angle Glaucoma or Ocular Hypertension in both eyes. Participants must understand the study and sign a consent form.

Inclusion Criteria

Informed consent dated and signed.
I have been diagnosed with glaucoma or high eye pressure in both eyes.

Exclusion Criteria

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.
I have a specific type of glaucoma not caused by an eye injury.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive T4090 or Rhopressa® ophthalmic solution to assess ocular hypotensive efficacy and safety

7 weeks
Multiple visits for IOP measurement at specified time points

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rhopressa®
  • T4090
Trial Overview The trial aims to compare the effectiveness and safety of two concentrations (0.2% and 0.3%) of T4090 ophthalmic solution against Rhopressa® in reducing eye pressure.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: T4090 0.3%Experimental Treatment1 Intervention
Group II: T4090 0.2%Experimental Treatment1 Intervention
Group III: Rhopressa®Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laboratoires Thea

Lead Sponsor

Trials
64
Recruited
6,900+

Citations

NCT06394973 | Efficacy and Safety Assessment of T4090 ...The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
Efficacy and Safety Assessment of T4090 Ophthalmic ...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%) ...
Effectiveness of Netarsudil as an Additional Therapy for ...Moreover, it was successful in achieving a pre-specified target IOP in 58% of eyes for which glaucoma laser or surgery would be the only ...
Effect of Rhopressa on Intraocular Pressure (IOP) in ...The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes. Detailed Description.
Top Glaucoma Clinical Trials | PowerT4090 vs Rhopressa for Glaucoma. Memphis, Tennessee. The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 ...
Efficacy and Safety Assessment of T4090 Ophthalmic Solution ...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 ...
T4090 vs Rhopressa for Glaucoma · Info for ParticipantsThe 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 ...
T-4090 - Drug Targets, Indications, PatentsSafety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients. 100 Clinical Results associated with T-4090. Login to view more data.
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