What side effects are associated with this type of intervention?

Common treatments for ocular hypertension, such as latanoprost, can cause side effects including changes in the cornea, iris, and retina, as well as hyperpigmentation. Patients may experience eye irritation, redness, and increased pigmentation of the iris. Other IOP-reducing medications may also lead to similar ocular side effects, including dry eyes, blurred vision, and conjunctival hyperemia. It is important for patients to discuss these potential side effects with their doctor to determine the best treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for ocular hypertension include prostaglandin analogs (e.g., latanoprost), which increase aqueous humor outflow, and beta-blockers (e.g., timolol), which reduce aqueous humor production. Other treatments include alpha agonists (e.g., brimonidine), carbonic anhydrase inhibitors (e.g., dorzolamide), and Rho kinase inhibitors (e.g., netarsudil). These medications help manage intraocular pressure to prevent glaucoma progression.

What other types of research exist?

Promising novel alternatives for ocular hypertension treatment in 2024 include: 1) Rho kinase inhibitors such as ripasudil and netarsudil, which improve aqueous humor outflow; 2) Adenosine receptor agonists like trabodenoson, which enhance trabecular meshwork outflow; and 3) Modified prostaglandin analogs such as latanoprostene bunod, which increase uveoscleral outflow and nitric oxide-mediated trabecular outflow.

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T4090 Eye Drops for Glaucoma and Ocular Hypertension

Phase 1 & 2

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 with open-angle glaucoma or ocular hypertension

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 22 days

Awards & highlights

Summary

This trial is testing a new treatment called T4090 to see if it is safe for people. The study includes a wide range of participants to ensure the treatment does not cause harm.

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 allergic to the trial medication, pregnant or breastfeeding women, or anyone with recent eye trauma or significant inflammation.

What is being tested?

The study is testing T4090 eye drops containing Kinezodianone R hydrochloride against a placebo to assess their safety in treating patients with ocular hypertension or glaucoma.

What are the potential side effects?

While specific side effects are not listed, they may include typical reactions related to eye drop use such as discomfort, redness, itching, swelling, and possible allergic responses.

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 glaucoma or high eye pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 22 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 22 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 22 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ocular and systemic adverse events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: T4090Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

named "Vehicle" in the study protocol.

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

The most common treatments for Ocular Hypertension (OHT) include medications that lower intraocular pressure (IOP) by either decreasing the production of aqueous humor or increasing its outflow. Prostaglandin analogs, such as latanoprost, enhance uveoscleral outflow, while beta-blockers like timolol reduce aqueous humor production. Alpha agonists (e.g., brimonidine) and carbonic anhydrase inhibitors (e.g., acetazolamide) also decrease aqueous humor production. These treatments are vital for OHT patients as they help prevent the progression to glaucoma, which can lead to irreversible vision loss. Understanding these mechanisms is important for patients to appreciate how their medications work to protect their vision, and it may provide context for new treatments like T4090, which aim to achieve similar outcomes through potentially novel mechanisms.

[Approaches in medical treatment in glaucoma (author's transl)].Netarsudil for the Treatment of Open-Angle Glaucoma and Ocular Hypertension: A Literature Review.[Medication assisted activation of unveoscleral outflow of intraocular fluid in glaucoma: pathogenic aspects].

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Who is running the clinical trial?

Laboratoires TheaLead Sponsor

57 Previous Clinical Trials

6,671 Total Patients Enrolled

7 Trials studying Ocular Hypertension

2,498 Patients Enrolled for Ocular Hypertension

~12 spots leftby Dec 2024

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