T4090 Eye Drops for Glaucoma and Ocular Hypertension

Overseen By Corentin LECAMUS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Laboratoires Thea

Disqualifiers: Trauma, Infection, Inflammation, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of T4090 eye drops for individuals with open-angle glaucoma or ocular hypertension (high eye pressure). The study compares the new eye drops to a placebo (a substance with no active medicine) to assess safety. Suitable participants have been diagnosed with open-angle glaucoma or ocular hypertension in both eyes and have not experienced recent eye trauma or infections. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop 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 ask the trial coordinators for more details.

Is there any evidence suggesting that T4090 Eye Drops are likely to be safe for humans?

Research shows that the safety of T4090 eye drops is still under investigation. Specific safety information for T4090 is not yet available. However, it resembles other eye treatments like Carteolol and Timolol, which patients usually tolerate well. These treatments are often used for conditions like glaucoma and high eye pressure.

As this trial is in its early stages, the primary goal is to ensure the treatment's safety for people. Researchers are closely monitoring participants' responses to the eye drops, checking for any side effects or issues. Although specific safety data for T4090 is not yet available, ongoing studies aim to confirm its safety for human use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for glaucoma and ocular hypertension, which typically include medications like beta blockers or prostaglandin analogs, T4090 Eye Drops are unique because they potentially offer a new mechanism of action. Researchers are excited about T4090 because it targets a different pathway to reduce intraocular pressure, which could mean fewer side effects and improved effectiveness for patients. Additionally, this eye drop formulation could offer a more convenient and comfortable option for those who struggle with the side effects or application difficulties of current therapies. This fresh approach may significantly enhance patient adherence and outcomes in managing these eye conditions.

What evidence suggests that T4090 Eye Drops might be an effective treatment for glaucoma and ocular hypertension?

Research shows that T4090 eye drops might help reduce eye pressure in people with glaucoma or high eye pressure. In this trial, participants will receive either T4090 or a placebo called "Vehicle." Studies comparing T4090 to other treatments have shown promise in lowering this pressure, which is important for managing these eye conditions. Researchers have tested the main ingredient, Kinezodianone R HCl, in different strengths to evaluate its effectiveness. Although results are still early, the treatment has positively affected eye pressure, crucial for preventing vision loss in glaucoma patients. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Informed consent dated and signed.

Informed consent dated and signed

Exclusion Criteria

I have not had any serious injuries, infections, or inflammation in the last 6 months.

Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)

Pregnancy or breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive T4090 or placebo eye drops to assess safety

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• T4090 Eye Drops

Trial Overview 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.

How Is the Trial Designed?

Group I: T4090 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

named "Vehicle" in the study protocol.

Who Is Running the Clinical Trial?

Laboratoires Thea

Lead Sponsor

Trials

64

Recruited

6,900+

Published Research Related to This Trial

In a study of 165 patients with glaucoma, 38 experienced adverse effects related to the addition of timolol to their treatment regimen.

Timolol had to be discontinued in 15 patients (9%) due to these side effects, indicating a need for further double-masked studies to better understand the safety profile of timolol in glaucoma therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects experienced by patients taking timolol. McMahon, CD., Shaffer, RN., Hoskins, HD., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06394973

NCT06394973 | Efficacy and Safety Assessment of T4090 ... Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients with Open-angle Glaucoma or Ocular Hypertension.

2. withpower.com withpower.com/trial/phase-2-glaucoma-5-2022-a570d

T4090 Eye Drops for Glaucoma and Ocular Hypertension The study on the dorzolamide/timolol fixed combination (DTFC) shows that combining different components in eye drops can effectively lower intraocular pressure ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06394973/efficacy-and-safety-assessment-of-t4090-ophthalmic-solution-versus-rhopressar-ophthalmic-solution-in-patients-with-open-angle-glaucoma-or-ocular-hypertension

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%) ...

4. clinicaltrial.be clinicaltrial.be/en/details/27626?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Safety Assessment of T4090 Eye Drops in Ocular ... Primary outcomes. 1. Ocular and systemic adverse events. Ocular and ... Both eyes diagnosed open-angle glaucoma or ocular hypertension.

5. synapse.patsnap.com synapse.patsnap.com/drug/8828dda3b19649ab83388588d694de4d

T-4090 - Drug Targets, Indications, Patents Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients. 100 Clinical Results associated with T-4090. Login to view more data.

6. ctv.veeva.com ctv.veeva.com/study/safety-assessment-of-t4090-eye-drops-in-ocular-hypertensive-or-glaucomatous-patients

Safety Assessment of T4090 Eye Drops in Ocular ... The study purpose is to evaluate the safety of T4090. Enrollment. 120 estimated patients. Sex. All.

7. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-glaucoma-safety-assessment-t4090-eye-drops-ocular-hypertensive-trial-nct05389267

Safety Assessment of T4090 Eye Drops in Ocular ... This study aims to assess the safety of T4090 eye drops for patients dealing with ocular hypertension or glaucoma without making any ...