What side effects are associated with this type of intervention?

Common treatments for ocular hypertension that reduce intraocular pressure by increasing aqueous humor outflow, such as prostaglandin analogs like Bimatoprost, often cause side effects including ocular hyperemia (redness), eye irritation, eyelash growth, and changes in iris pigmentation. Less frequent side effects include dry eye, blurred vision, and conjunctival hyperemia. These side effects are typically mild and reversible upon discontinuation of the medication.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of ocular hypertension, primarily focusing on reducing intraocular pressure by increasing aqueous humor outflow. Notable examples include prostaglandin analogs like Bimatoprost (Lumigan®), which enhance uveoscleral outflow, and Rho kinase inhibitors such as Netarsudil (Rhopressa®), which improve trabecular meshwork outflow. These treatments are designed to lower IOP effectively, similar to the investigational drug T4032 being studied for its potential to increase aqueous humor outflow.

What other types of research exist?

Promising novel alternatives to T4032 for ocular hypertension patients include selective laser trabeculoplasty (SLT) and new pharmacologic agents such as netarsudil and latanoprostene bunod. SLT has shown efficacy comparable to medical therapy with fewer medications needed. Netarsudil increases aqueous humor outflow through the trabecular meshwork, and latanoprostene bunod works by both increasing outflow through the trabecular meshwork and relaxing the uveoscleral pathway. Both have demonstrated significant IOP reduction in clinical trials.

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Prostaglandin Analog

Unpreserved Bimatoprost for Glaucoma

Phase 3

Waitlist Available

Research Sponsored by Laboratoires Thea

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Both eyes diagnosed open-angle glaucoma or ocular hypertension

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week12

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new treatment called T4032. It aims to see if T4032 is as effective as Lumigan® 0.01% for patients with glaucoma or high eye pressure. The study will compare how well each treatment reduces eye pressure.

Who is the study for?

This trial is for individuals with open-angle glaucoma or ocular hypertension in both eyes who have signed an informed consent. It's not suitable for those with recent eye trauma, infection, significant inflammation, known allergies to the medication components, or if they are pregnant or breastfeeding.

What is being tested?

The study aims to show that T4032 (a preservative-free version of Bimatoprost 0.01%) is just as effective as Lumigan® 0.01% in treating patients with ocular hypertension or glaucoma.

What are the potential side effects?

Potential side effects may include redness of the eyes, growth of eyelashes, itchy eyes, dryness or discomfort around the eye area; however specific side effects for T4032 will be monitored and compared to Lumigan®.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Both of my eyes have been diagnosed with open-angle glaucoma or high eye pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week12

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: T4032Experimental Treatment1 Intervention

Group II: LumiganActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bimatoprost Ophthalmic

2023

Completed Phase 3

~730

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ocular hypertension, such as prostaglandin analogs (e.g., bimatoprost) and Rho kinase inhibitors, primarily work by increasing the outflow of aqueous humor from the eye, thereby reducing intraocular pressure (IOP). Prostaglandin analogs enhance uveoscleral outflow, while Rho kinase inhibitors improve trabecular meshwork outflow. Lowering IOP is crucial for ocular hypertension patients as it helps prevent the progression to glaucoma, which can lead to irreversible vision loss. Effective management of IOP through these mechanisms is essential for preserving vision and maintaining quality of life.

Effects of Rho Kinase Inhibitors on Intraocular Pressure and Aqueous Humor Dynamics in Nonhuman Primates and Rabbits.